Quality Manager

The Quality Manager is responsible for leading the Quality Management System (QMS) and ensuring that all products, materials, and processes meet applicable requirements for ISO 13485, customer specifications, regulatory expectations, and internal quality standards. This role drives ongoing QMS improvement initiatives, oversees quality assurance activities, and provides technical leadership for all quality-related functions.

Required Qualifications

- Bachelor’s degree preferred; equivalent experience considered.

- 5+ years of quality experience in a regulated manufacturing environment.

- Strong knowledge of ISO 13485 and its application within a supplier environment.

- Experience with risk-based quality tools (FMEA, control plans, validation, SPC).

- Demonstrated success driving QMS improvements and leading audits.

- Strong analytical, problem-solving, and decision-making abilities.

- Excellent communication skills with ability to interface directly with customers and regulatory auditors.

- Proficiency in Microsoft Office applications; experience with ERP/QMS software preferred.

Preferred Qualifications

- Experience in printing, adhesive converting, or flexible materials manufacturing.

- Knowledge of medical device regulatory requirements including 21 CFR 820.

- Experience with PPAP, process validation, and capability analysis.

- Familiarity with supplier quality management and external auditing.

Key Competencies

- Strong leadership and team-building capability

- Continuous improvement mindset

- High attention to detail and documentation accuracy

- Ability to work in a fast-paced, customer-driven environment

- Excellent organizational and project management skills

- Professional demeanor and strong customer-facing communication skills

Physical Requirements & Work Environment

- Ability to sit, stand, walk, and occasionally lift up to 25 pounds.

- Regular exposure to converting and printing equipment environments.

- Use of appropriate PPE as required.