Quality System Specialist

Sussex IM is a custom, plastic injection molding manufacturer located in Sussex, WI. The company’s history goes back to 1977 and has since grown into a locally owned organization that employs around 350 people. Interested in learning more about what we do? Check out our website:

JOB DESCRIPTION

Position: Quality System Specialist

Department: Quality Assurance

Immediate Supervisor: Production Quality Manager

Classification: Exempt

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.

• 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

• 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.

• 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.

• 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.

• 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 orts any unsafe conditions to a manager.

Performs other related duties and assignments as assigned or 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.

• 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).

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

• 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.

Job Type: Full-time

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

• Quality role w/i ISO-certified environment: 5 years (Required)
• ISO 9001:2015 & ISO 13485:2016: 5 years (Required)
• doc control, CAPA and auditing: 3 years (Required)
• certified internal auditor for ISO 9001 &/or ISO 13485: 3 years (Required)

• Sussex, WI 53089 (Required)

Work Location:

In person