Careers

Summary of Position 

The Quality System Specialist supports the development, maintenance, and continuous improvement of the company’s Quality Management System (QMS) in compliance with ISO 9001 and ISO 13485 standards. This role ensures that all quality processes, records, and documentation meet applicable regulatory and customer requirements. The Specialist will collaborate with cross-functional teams to promote a strong quality culture, maintain compliance, and drive system effectiveness.

Essential Duties, Responsibilities, & Authority

• Quality Management System Oversight
  • Maintain and continuously improve the Quality Management System to comply with ISO 9001 and ISO 13485 standards.
  • Ensure controlled distribution, revision, and accessibility of procedures, forms, and work instructions.
  • Supports Management Review
• Audits & Compliance
  • Plan, schedule, and conduct internal audits of ISO 9001 and ISO 13485
  • Track and verify completion of QMS corrective actions from audits, nonconformances, or management reviews.
  • Lead preparation for customer and supplier audits, external certification, regulatory and surveillance audits.
  • Supports supplier qualification.
• Document Control & Change Management
  • Administer the document control process, including approvals, revisions, and obsolescence.
  • Support Engineering Change Notices (ECNs) and quality-related change requests to ensure compliance with ISO standards.
• CAPA & Nonconformance Support
  • Facilitate and document Corrective and Preventive Actions (CAPA) for QMS findings.
  • Ensure root cause analysis and effective verification of implemented solutions.
  • Support risk management activities related to quality system compliance.
• Training & Awareness
  • Provide training to employees on ISO and regulatory requirements, documentation procedures, and quality system changes.
• Assist in implementing and maintaining ERP-based quality modules.
• Promote continuous improvement initiatives to enhance system efficiency and product quality.
• Follows Sussex IM’s environmental policies to protect and minimize our impact on the environment.
• Maintains a safe 5S working environment to minimize the possibility of an injury. Acts in a safe manner at all times and ensures that those around them do not put themselves or others at risk. Reports any unsafe conditions to a manager.
• Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

• Required:
  • Bachelor’s degree in Quality, Engineering, or an equivalent in a Quality management system.
  • Working knowledge of ISO 9001:2015 and ISO 13485:2016 requirements.
  • Experience with document control, CAPA, and internal auditing.
  • Certified Internal Auditor for ISO 9001 and/or ISO 13485.

• Preferred:
  • Experience in the manufacturing environment.
  • Experience with electronic QMS or ERP-based quality management tools.
  • ASQ certification and Certified ISO 13485 is a plus.
  • Knowledge of FDA rules and regulations as they relate to medical device manufacturing (21 CFR Part 820 and Good Manufacturing Practices).

Job Specification

• Minimum of 5-7 years of experience in a quality systems role within a regulated or ISO-certified environment.

Knowledge, Skills & Abilities

• Strong attention to detail, organizational skills, and documentation accuracy.
• Excellent written and verbal communication skills.
• Knowledge of quality management principles and regulatory compliance.
• Analytical and problem-solving mindset, including risk-based thinking.
• Ability to manage multiple priorities and meet deadlines.
• Collaborative and proactive approach to quality improvement.
• Commitment to maintaining a culture of compliance and continuous improvement.

Summary of Position

The Cell Lead coordinates all activities of his/her team to meet specific production, quality, and scheduling targets. This includes, but is not limited to, preparing all production and daily tasks in advance of the start of the shift, completing all necessary activities at the end of the shift, coordinating activities with other Cell Leads, effectively placing and training Operators within the team, ensuring that they are productive, and are provided all the necessary tools and resources. This also includes completing start-up, shutdown, and work order changes. The Cell Lead provides training and assistance in quality, auditing, record keeping, etc., to ensure the team’s targets are achieved. In addition, he/she ensures that assigned rework projects run smoothly.

Essential Duties, Responsibilities, & Authority

• Starts-up checklist verification that the line was cleared, cleaned and set up for a new work order.
• Verifies line layout, work orders, and production/quality documents.
• Verifies work order to make sure all items on it are at the press (WIP, components, packaging, labels, IMLs, tape).
• Obtains scales and product/limit standards.
• Performs label verification and labor counts.
• Reviews the BOM, and adds the number to the press.
• Audits GOJO, MRE, MRY, SSAP.
• Completes customer-specific forms (ex. lot control forms).
• Completes non-conforming product notification forms for any non-conforming material.
• Completes non-conforming components form as necessary.
• Gets standard tools for operators (ex. nippers, gloves, green tape, etc.).
• Takes parts to QA2 three times a shift.
• Reviews goal boards.
• Completes production reporting and start/stop counts.
• Follows the production cell audit checklist for the job. This verifies the following: GMP, safety, 5S, visual inspection, scale verification, camera verification, labor count, and cycle time.
• Checks line clearance.
• Reviews batch record/GDP and submits to QA.
• Completes IML/heat transfer and closeout form.
• Returns product/limit standards to QA2 and submits last shots.
• Oversees rework and completes required paperwork.
• Serves as backup for Admin Supervisor and Metrology Specialist as needed.
• Provides direction and good communication to Op 3s and trains operators.
• Follows Sussex IM’s environmental policies to protect and minimize our impact on the environment.
• Maintains a safe 5S working environment to minimize the possibility of an injury. Always acts in a safe manner and ensures that those around them do not put themselves or others at risk. Reports any unsafe conditions to a manager.
• Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

• High School diploma or equivalent preferred

Job Specification

• Minimum of 1 year’s experience in plastic injection molding manufacturing
• Must have completed training for all three job tiers
• Must be able to work with a diverse workforce.
• Requires keen vision (20/20 corrected) and normal color perception.
• Must have proven good attendance record (<40 hours/year)

Knowledge, Skills & Abilities

• Uses good interpersonal communication techniques to work with subordinates and/or co-workers. Is courteous and helpful when interacting with fellow employees. Helps to create a positive work environment.
• Must have basic math and computer skills.
• Demonstrated knowledge of the injection molding process and Operator skills.
• Critical thinking skills
• Takes initiate to gather and pass information to help others.

Summary of Position

The Quality Inspector is responsible for ensuring that all Sussex IM manufactured products meet the customers’ specifications by supporting the manufacturing teams.

Essential Duties, Responsibilities, & Authority

• Performs in-process inspections requiring variable/attribute test methods that require gauges. Examples include tensile testing, moisture analysis, leak testing, running programs on the CMM, go – no go gauging, metrology involving micrometers, calipers, digital gauges. Records measurements in IQMS.
• Follows established metrology, safety, and test equipment procedures.
• Ensures all metrology lab procedures are current and up to date.
• Assists with gauge calibration.
• Performs basic maintenance to keep QA equipment (QA1, QA2, Inspection Stations) clean     and in good working order. Reports all damaged, nonfunctional, or out of calibration equipment.
• Communicates all relevant quality information with the quality and manufacturing      personnel on all shifts.
• Maintain QA offices and storage areas in a neat, orderly condition according to 5S standards.
• Performs Quality projects/duties as directed by the Quality Lead including gauge R&R, and capability study measurements for NPD.
• Maintain a safe working environment. Report any unsafe conditions.
• Follow Sussex IM’s environmental policies to protect and minimize our impact on the environment.
• Maintains a safe 5S working environment to minimize the possibility of an injury. Always acts in a safe manner and ensures that those around them do not put themselves or others at risk.
• Reports any unsafe conditions to a manager.
• Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

• High school diploma or equivalent preferred.
• Quality training and certification a plus.

Job Specification

• Minimum of one year experience in a Quality Inspector role or a Cell Lead/Op3 Blue role.
• Quality training and certification a plus.
• Requires 20/20 vision corrected.
• Must have normal color perception. Must not be colorblind.
• Ability to lift 40 lbs.

Knowledge, Skills & Abilities

• Uses good interpersonal communication techniques to work with subordinates and/or co-workers.  Is courteous and helpful when interacting with fellow employees.  Helps to create a positive work environment.
• Working knowledge of PC based software and data entry.
• Ability to communicate clearly and effectively in a multilanguage environment.
• Demonstrated ability to properly use various hand measuring tools (i.e., micrometer, dial caliper, dial indicator, force gauges, etc.).
• Knowledge of gauge calibration systems and its relation to ISO 9001/13485 standards
• Proficiency in the use of various measuring devices, e.g., optical comparator, force gauges, dial indicator, micrometer, etc.
• Ability to focus on improving processes and address nonconformances.
• Attention to detail.
• Demonstrates accuracy and thoroughness and monitors own work to ensure quality.
• Self-starter with can-do attitude

Summary of Position

The Set-Up Technician position is responsible for removing molds from completed jobs and setting up the next scheduled jobs. In addition, the Set-Up Tech adjusts and troubleshoots the operations of semi-automatic and automatic injection molding machines to maintain the flow and quality of products being produced.

Essential Duties, Responsibilities, & Authority

• Sets up molds. Installs knockout pins in the mold (all must be the SAME LENGTH). Mounts, aligns, and connects plastic molding dies on press platens. Must ensure that the machine’s safety features (e.g., drop bar, safety gates) are properly set. All Safety guards must be in place. Connects water and air lines to mold where necessary and adjusts controls to regulate the mold temperature.
• Sets machine controls to regulate clamping pressure and speeds. Sets control for injection speeds and pressures. Sets all machines’ timers (e.g., curing time, boost time, hold time and open time) to obtain the proper cycles. Changes machine screw when necessary to obtain proper color. Record all troubleshooting adjustments on the Supervisors Checklist.
• Cleans the entire machine and washes the floor around the machine. All work areas must be kept clean and safe.
• Cycles-in machine. Examines the sample parts for defects, such as flash, sinks, shorts, splay, cracks and closed holes, proper inserts, and codes, and adjusts machine set up to eliminate defects.
• Takes first good shots to Cell Lead for approval.
• Arranges work area and assists in the set-up of auxiliary equipment as required.
• Instructs operators on operating procedures and safety hazards as they pertain to each job after it is set up.
• Trouble shoots operating difficulties by referring to the Sussex IM Trouble Shooting Guidelines. Adjust equipment and machine cycles as necessary to correct molding problems such as shorts, flash, etc.
• Twice during the shift, verifies that we are free of nozzle leaks, Process windows are completed, and parameters are within the stated parameters and Cycle time is matched to the BOM.
• At completion of run, responsible for removing mold from press. Sprays mold with rust preventative, disconnects water lines and blows water out of mold. No mold can be stored with water in water lines.
• Responsible for storing mold in designated storage space. Must tag mold with any needed mold repair.
• Follows Sussex IM’s environmental policies to protect and minimize our impact on the environment.
• Maintains a safe 5S working environment to minimize the possibility of an injury. Acts in a safe manner always and ensures that those around them do not put themselves or others at risk. Reports any unsafe conditions to a manager.
• Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

• High school diploma or equivalent preferred.

Job Specification

• Minimum of 3 years’ set-up experience in plastic injection molding

Knowledge, Skills & Abilities

• Basic computer skills including IQMS systems.
• Uses good interpersonal communication techniques to work with subordinates and/or coworkers. Is courteous and helpful when interacting with fellow employees. Helps to create a positive work environment.
• Must have good documentation skills.
• Strong material knowledge
• Demonstrated machine knowledge.
• Strong processing knowledge
• Advanced set-up knowledge
• Critical thinking skills
• Ability to gather data and think creatively.
• Good attendance
• Ability to lift to 50 lbs. to shoulder height.

Summary of Position

Under the direction of the Maintenance Manager, a Maintenance Technician I maintains injection
presses and auxiliary equipment to ensure that they are always in safe and excellent working
order. The Maintenance Technician I follows maintenance schedules for all equipment and
ensures all necessary preventative maintenance is completed on a timely basis.

Essential Duties, Responsibilities, & Authority

• Responsible for ensuring that the daily routine maintenance is performed on all molding equipment.
• Works independently or with other maintenance technicians to troubleshoot any major
  mechanical or electrical problems.
• Works with outside contractors for problems that can not be solved internally.
• Ensures that all safety systems and guarding on all molding machines and auxiliary
  equipment are kept in good working order.
• Responsible for doing any facility maintenance that is outside the ability of the facilities
  maintenance team.
• Documents all activity in the MRO module.
• Makes recommendations and upon approval places orders for the necessary parts to
  improve or repair machinery.
• Assists in the moving of machinery within the plant as well as hooking-up and leveling
  new machines.
• Responsible for performing maintenance functions on all auxiliary equipment.
• Ensures that all work areas are always kept clean and organized.
• Learns, practices, and supports lean manufacturing tools to assist the Company in the
  continuous improvement process.
• Follows Sussex IM’s environmental policies to protect and minimize our impact on the
  environment.
• Maintains a safe 5S working environment to minimize the possibility of an injury. Acts in a
  safe manner at all times and ensures that those around him/her do not put themselves or
  others at risk. Reports any unsafe conditions to the supervisor.
• Performs other related duties and assignments as assigned or required.

Required Education, Credentials, & Certifications

• High school diploma or equivalent.
• Completion of Maintenance Apprenticeship Program or the equivalent work experience.

Job Specification

• Entry Level to 5 years experience in manufacturing maintenance repair environment.

Knowledge, Skills & Abilities

• Good basic understanding of mechanical, electrical, pneumatic and hydraulic systems.
• Ability to operate machinery and other technical equipment.
• Strong analytical problem-solving skills.
• Basic computer skills are required including basic email, entering and modifying
  spreadsheets, and usage of IQMS / MRO.
• Ability to work independently.
• Ability to weld.
• Ability to operate forklift.
• Ability to use small power hand tools safely.
• Attention to detail.
• Uses good interpersonal communication techniques to work with co-workers. Is courteous
  and helpful when interacting with fellow employees. Attends available interpersonal skill
  training courses. Helps create a pleasant work environment.