- Conducting gap analysis for transition from ISO 9001 to ISO 13485.
Improving, developing, implementing, and maintaining QMS-related activities and processes required for ISO certification.
- Supervising supply chain verification, hosting supplier audits.
- Overseeing and maintaining the Quality Policy and related QMS elements (i.e., change control, quality records, CAPA, document control, etc.)
- Preparing for and hosting all second and third-party audits.
- Defining and documenting the responsibility, authority, and interrelation of key personnel managing the quality systems.
- Conducting scheduled reviews of key QMS indicators and performance of quality systems to assess their continued suitability, adequacy, effectiveness, and efficiency; issuing periodic reports to management.
- Developing and maintaining a customer complaint system to ensure complaints are logged, investigated, and resolved in a timely manner.
- Writing required policies, procedures, and protocols to ensure compliance with current regulations and best industry practices.
- Helping to develop solutions for improving product quality and production, and resolve customer product quality issues with the involvement of the R&D department.
Communicate quality control information to all relevant organizational departments, outside vendors, or contractors.
- Ensuring all quality standards and regulatory requirements are met - includes meeting ISO and OSHA standards, and maintaining compliance with all local, state, and federal regulations.
Qualifications and Background
- Bachelor of Science degree or equivalent in molecular biology, chemistry or life science-related field.
- A certificate in quality assurance is a plus.
- Minimum of 2 years of previous experience in quality assurance or a similar field.
- Working knowledge of tools, methods, and concepts of quality assurance, including quality systems, Good Manufacturing Practices (GMP), and ISO standards (13485 preferred), with setup experience preferred.
- Understanding of risk management principles and ability to apply these principles to day-to-day quality management activities, quality and compliance issues, and business challenges.
- Critical thinker with the ability to read, analyze, and interpret technical data.
- Ability to lead, train, motivate, and work effectively within a team.
- Excellent oral and written interpersonal communication skills.
- Good conceptual, analytical, problem solving, planning, and organization skills, including demonstrated prior accomplishments.
- Ability to multi-task and wear multiple hats, assisting other departments as needed.
- Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard.
- Proficient in Microsoft Office (especially Word, Excel, and Powerpoint).
- Ability to speak, write and read English required.
- Standing or sitting for long periods of time may be necessary.
- Ability to travel internationally less than 5% may be necessary.
- Some lifting (up to 25 pounds) may be necessary.