Description For Quality Manager
We are seeking a Quality Manager to join our Quality team. This role plays a critical role in ensuring our innovative products are designed, developed, and manufactured to the highest standards of quality, safety, and regulatory compliance. This position acts independently on matters affecting product quality and compliance.
Major duties and responsibilities
Quality System Management
‣ Establish and Maintain Quality Management System.
‣ Maintain QMS Manual and associated procedures.
‣ Review and interpret quality/regulatory compliance requirements and ensure that they are implemented through company policies and procedures.
‣ Develop regulatory compliance and quality plans and strategies in concert with affected functional areas.
‣ Prepare and/or review FDA and other regulatory applications and documents, including Medical Device License Applications and Medical Device Reports as required.
‣ Review and approve all new and changed manufacturing processes to ensure compliance with requirements of FDA and FDB.
‣ Provide support and guidance to biocompatibility and environmental control programs.
‣ Review and approve all product labeling and marketing materials to ensure compliance with regulatory requirements.
‣ Manage Document Change Control
‣ Manage supplier quality management/audit program.
‣ Manage internal quality audit program.
‣ Manage Medical Device Reporting and complaint management activities.
‣ Develop, implement and supervise the non-conformance (NCR) and CAPA systems.
‣ Initiate and Chair Material Review Board (MRB) if/as required.
‣ Ensure training on all released QMS procedures and quality records is current.
‣ Ensure calibration system for all inspection, production and R&D instruments is established and maintained.
Requirements
Education requirements
Bachelor’s degree required, preferably in engineering
Experience requirements
Minimum 6 years Quality management experience in an FDA regulated medical device or related industry.
Familiar with 21 CFR 820, 21 CFR Part 11, ISO 13485 and ISO 14971
Experience in medical device start-ups
Experience in managing sterilization controls for a Class II or Class III sterile product (EO Preferred)
Working knowledge of current FDA Quality Systems Regulation and equivalent international requirements for medical devices.
Direct, recent involvement in 510k Submissions, IDE Submission, and/or CE mark filings (Desired)
Physical requirements
Ability to stand, walk, or sit for extended periods. Capacity to move between work areas, including offices, production floors, and warehouses.
Required skills/abilities
- Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
- Excellent verbal and written communication skills are required.
- Ability to work cross-functionally to achieve company goals and quality objectives.
- Excellent interpersonal, organizational, communication & leadership skills
- Knowledge of Statistics and ASTM test methods preferred
- Thrive in a fast-paced and dynamic work environment
- Strong oral and written communication skills.
- Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
Manual dexterity
- Lifting up to 50 lbs.
Occasional PPE
- Pay: $28.00 - $38.00 per hour
- Expected hours: 40.0 per week
Benefits
401(k)
Dental insurance
Disability insurance
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
- Work Location: In person