The Senior Manager of Quality is responsible for all aspects of Quality Assurance at Anika’s Sarasota facility including, but not limited to; ensuring compliance with applicable regulations and standards, assist in post market surveillance activities and continuously monitoring the organization identifying opportunities for improvement. This position will expect to work collaboratively with other functions like Manufacturing, Research and Development, and Supply Chain.
- Manage a team of Quality Assurance, Quality Engineering and Quality Control professionals.
- Ensure the quality system requirements are effectively established and maintained in accordance with applicable regulations and standards, including, but not limited to FDA Quality System Regulation, and ISO 13485.
- Oversee the implementation of both corporate and site-level QMS processes at the Sarasota manufacturing facility
- Report on the performance of the quality system to management with executive responsibility.
- Manage the internal audit process; conduct internal audits of Quality System components, and/or arrange for external parties to conduct audits.
- Serve as the backup Management Representative and a backup point of contact for external audits.
- Assist with design and development deliverables (e.g. design reviews, design and risk management documentation, shipping and packaging tests, sterilization validation, and regulatory submissions).
- Oversee document control and records management.
- Develop supplier quality oversight, qualification and performing supplier audits, as necessary.
- Prepare quality agreements with key suppliers and economic operators.
- Work with management to establish and update metrics for monitoring performance, as necessary.
- Identify opportunities for improvement and/or trends and initiate necessary preventive or corrective actions.
- Assist HR and management team to ensure employee training records are prepared and maintained for employees.
- Follow Anika Safety and Health Program policies and procedures.
- Oversee the quarterly environmental monitoring testing program.
- Authority to request, review and approve test reports including but not limited to those related to performance testing, biocompatibility, material composition, dimensional inspection, etc.
- Assist in maintenance and support the calibration process
- Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
- Exceptionally strong leadership and influencing skills, and willingness to move into site leadership role.
- Must have ability to make effective presentations to all levels of the organization.
- The proven ability to prioritize and manage multiple projects and meet deadlines is required.
- Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
- Experience building a high performing team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
Desired Experience, Knowledge, and Skills:
- Bachelor’s degree (or international equivalent) in a science, medical or engineering field, Master’s degree preferred
- 8+ years’ experience in a regulatory and/or quality compliance role, including 5+ years of leadership, supervisory, managerial, and coaching experience
- Experience interacting with regulatory authorities
- ISO 13485 auditing certification preferred
- Proven experience in leading and managing QA functions through teamwork, collaboration, and open communication
- Successful track record of working in a fast-paced environment while building strong partnerships with others internal and external to the organization
- Thorough knowledge and understanding of medical device regulations and standards, including but not limited to FDA QSR, Canada medical device regulations, EU Medical Device Directive, EU MDR, ISO 13485 and other applicable industry requirements is required.
- Ability to work at a desk;
- Ability to lift up to 20 lbs;
- The employee might be frequently required to climb stairs, kneel, or crouch, in accordance with job duties.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.