Senior Quality Engineer - Medical Devices & Regulatory

Anika Therapeutics; Bedford (MA); On-site; USD 122,000 - 152,000; Full time

Job summary

Anika Therapeutics is seeking a Senior Quality Engineer to support the establishment and maintenance of the Anika Quality System and contribute to product quality across the lifecycle.

Responsibilities include leading design controls, risk management, CAPAs, and audits, while collaborating with RD, Regulatory, Clinical, Marketing, and Manufacturing to ensure regulatory compliance and continuous improvement.

Qualifications

• Bachelor’s degree in Science, Engineering or related discipline; Master’s Degree preferred.
• Minimum of 5 years related experience and demonstrated working knowledge of scientific principles in medical device manufacturing, product development and design control and risk management.
• Experience leading projects across functions and sites.
• Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices.
• Demonstrated experience working with US and international regulations/standards including 21 CFR, 820, 210, 211, ISO 13485, EU MDR, and MDDs.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Teams).
• Experience with statistics and statical analytics tools (e.g., Minitab) preferred.
• Strong written and verbal communication skills.
• Experience in delivering presentations on complex quality-related issues and topics.
• Working knowledge of Six Sigma preferred.
• Ability to travel up to 15%.

Responsibilities

• Guide project teams through quality system requirements, design controls, and regulatory standards during all development phases.
• Participate in the development of customer requirements (user needs) and design inputs; verify and validate design requirements.
• Drive quality through the lifecycle from DHF development to design transfer for manufacturing.
• Facilitate ISO 14971 risk management and integrate outputs with design and regulatory.
• Lead root cause investigations for manufacturing issues, complaints, and CAPAs with cross-functional teams.
• Review and approve CAPAs, Change Controls; manage internal and external audits.
• Develop, review, and approve validation and verification protocols and reports.
• Collaborate with engineering on statistically sound experiments and process validations.
• Support post-market sustaining activities, like design changes and CAPA follow-up.
• Perform gap analyses for regulatory updates and implement actions.

Skills

Quality system

Design controls

Risk management

CAPA management

Audits

Statistical analysis

Minitab

FDA/Regulatory

MS Office

Communication

Travel up to 15%

Education

Bachelor’s degree in Science/Engineering

Master’s degree preferred

Tools

Microsoft Office

Minitab

Job description

Anika Therapeutics is seeking a Senior Quality Engineer to support the establishment and maintenance of the Anika Quality System and contribute to product quality across the lifecycle.

Responsibilities include leading design controls, risk management, CAPAs, and audits, while collaborating with RD, Regulatory, Clinical, Marketing, and Manufacturing to ensure regulatory compliance and continuous improvement.