Quality Assurance Specialist - Document Control/Medical Device

Job Description

Job Description

At Cadence, we don’t just manufacture medical devices—we help bring life-changing technologies to the people who need them most. As a trusted contract manufacturing partner, our work is defined by innovation, attention to detail, and an uncompromising commitment to quality.

We’re looking for a Quality Assurance Specialist who shares our passion for getting it right—every product, every time. In this critical role, you’ll help ensure our products meet the highest standards of safety, compliance, and performance, supporting both day-to-day operations and long-term improvement efforts.

What You’ll Do

As a QA Specialist, you’ll be a key contributor to the implementation and maintenance of both company and regulatory quality standards. Your work will span the full product lifecycle, supporting quality in our manufacturing operations and helping drive continuous improvement across the organization.

Key Responsibilities

• Maintain quality documentation (SOPs, work instructions, records).
• Support validation and verification activities.
• Perform quality inspections, audits, and root cause investigations.
• Ensure compliance with FDA, ISO, and customer requirements.
• Collaborate cross-functionally with Engineering, Production, and Supply Chain.
• Analyze and report on quality metrics and performance indicators.
• Lead or support nonconformance investigations and corrective actions.
• Work directly with suppliers to ensure incoming material quality.
• Contribute to risk assessments, process change validations, and compliance audits.
• Help deliver quality training and support document control processes.

What You Bring

• 3+ years of experience in quality assurance, preferably in a medical device or regulated manufacturing environment.
• Strong working knowledge of FDA, ISO 13485, and related regulatory standards.
• Experience with QMS platforms, ERP systems (SAP, Oracle, or similar), and data analysis tools like Excel, Tableau, or Power BI.
• Skilled in root cause analysis tools (5 Whys, Ishikawa/Fishbone, FTA).
• Comfortable interpreting technical documents and working with metrology tools.
• Ability to assess risk, document findings, and drive corrective action.
• Experience working in both office and manufacturing environments.
• Effective communicator and cross-functional collaborator.
• This role involves a blend of desk and production floor time. You should be able to navigate a manufacturing environment safely and effectively, use a computer for extended periods, and communicate clearly both verbally and in writing.

Why Join Us?

At Cadence, your attention to detail and commitment to quality will help shape life-changing medical technologies. You’ll be part of a collaborative, mission-driven team in an environment that values growth, innovation, and excellence.

Apply now to help us deliver on our promise of quality—every product, every time.