This position is responsible for supporting the effective establishment and maintenance of the Anika Quality System and contributing to the entire quality lifecycle for Anika’s products. This will include contributing to new product development with Quality expertise in design control, risk management, and human factors/usability engineering of medical devices, as well as driving continuous improvement in the quality management system to ensure compliance with regulatory requirements. This individual will collaborate and partner with Research & Development, Regulatory, Clinical, Marketing, and Manufacturing to achieve optimal results.
Specific 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; works with cross-functional team to ensure that customer requirements can be validated and design requirements can be verified.
- Drive quality through the entire product lifecycle, from initial design concepts and Design History File (DHF) development to design transfer for manufacturing.
- Facilitate the Risk Management Process in accordance with the latest version of ISO 14971; ensure integration of risk management outputs with design, process, and regulatory requirements.
- Drive root cause investigations for manufacturing issues, complaints, and CAPAs with full cross functional engagements.
- Review and approve CAPAs, Change Controls. Manage Internal and External Audit programs and maintain associated tracking logs. Has capability to manage these programs within the Electronic Quality Management system upon implementation.
- Develop, review, and approve validation and verification protocols/reports to ensure quality attributes and analysis are being conducted as part of new product development.
- Partner with engineering to execute statistically sound experiments, sampling plans, and process validations.
- Support post-market product sustaining activities, such as design changes, customer complaint investigations, and CAPAs.
- Conduct gap analyses for new/updated regulations and standards; develop plans and implement actions to ensure continued compliance for product design and the quality management system.
- Support development and implementation of company-wide quality initiatives.
- Support internal and external regulatory audits; may serve as lead facilitator.
- Performs other related duties as assigned.
Job Complexity:
Requires thorough knowledge of FDA, ISO, and other regulatory guidelines related to the development and manufacturing of medical devices. Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Experience, Knowledge and Skills Required:
- Requires a Bachelor’s Degree in science, engineering or related discipline; Master’s Degree preferred.
- Requires a 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 (i.e., 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%.
The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.
The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.