Job Summary:
This position is responsible for developing and maintaining all required documentation to support the Company’s medical device products and processes. This position will be instrumental in maintaining ISO 13485 Certification, maintaining regulatory compliance regarding the FDA and Health Canada, and maintaining CE Mark status.
General Functions:
- Will work closely with engineering, product management, suppliers, and staff to ensure product quality is built into devices and assist in meeting all goals for domestic and international product distribution.
- Will assist in preparation, review and approval of qualification and validation test plans and reports for all applicable equipment and product and assist in developing reporting for regulatory agencies and applicable testing companies.
- Will be handling CAPA, internal and external audits and leading company towards continuous improvement.
- Will manage the quality system, and continue to refine the modules, within Grand Avenue Software.
- Will be key player as we establish our product and brand in a competitive marketplace.
- Will manage all aspects of inventory control and flow.
The Key Contributions and Outcomes for this position are:
- Provide support for all cGMP compliance issues and maintaining ISO 13485 certification and Health Canada licensing.
- Develop, implement, and manage effective quality assurance policies and programs.
- Coordinate and train others on Company’s quality management system.
- Support the Design Control and Risk Management process.
- Complete all necessary regulatory submission documentation.
- Manage the Corrective and Preventive Action system (CAPA) inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
- Responsible for developing inspection criteria for RI, WIP, final testing and product release.
- Actively participate in resolution of product quality problems through interface with contractors, operations, sales, and customer reps.
- Act as principal liaison and audit leader for internal audits, regulatory audits, customer audits and visits.
- Fulfill the role of Management Representative, including the responsibility and authority to:
- Ensure processes necessary for the quality management system are documented and effectively maintained,
- Report to top management on the performance and effectiveness of the quality management system and any need for improvement,
- Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
- Conduct Management Reviews according to established procedures.
- Quality System document control.
- Responsibility for inventory control and management.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties and responsibilities may change with or without notice.
Qualifications:
- Strong working knowledge of regulatory requirements – FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards/regulations.
- Demonstrated ability to advocate product excellence and quality.
- Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.
- Demonstrated knowledge of validation testing methodologies and performance characterization.
- Bachelor’s degree in biomedical, mechanical, chemical or electrical engineering preferred, experience of 10 + years in medical device area acceptable.
- Experience with Grand Avenue Software is required.
- Experience with NetSuite, or similar software, is preferred.
