Summary:The Senior Quality Assurance Manager is responsible for leading the Quality Assurance function and ensuring the organization's Quality Management System (QMS) is effectively implemented, maintained, and continuously improved in compliance with applicable regulatory standards, customer requirements, and internal quality objectives. This position provides strategic leadership for quality systems, regulatory compliance, audit readiness, risk management, and continuous improvement initiatives within a regulated manufacturing environment.
Essential Duties and Responsibilities:- Lead, maintain and continuously improve the Quality Management System (QMS) in alignment with applicable regulatory requirements.
- Serve as primary quality leader for internal, customer, and regulatory audits and inspections
- Oversee CAPA, NCR, complaint handling, and escalation processes to ensure timely investigation, containment, root cause analysis, implementation and effectiveness verification.
- Ensure manufacturing and inspection processes are compliant, effective, and consistently executed through floor presence, audit, and process monitoring.
- Drive risk-based decision making across quality systems, supplier quality, manufacturing controls, and process improvement.
- Monitor and analyze quality metrics, trends, and KPIs to identify systemic issues, improve performance, and support management review activities.
- Partner with Operations, Engineering and Manufacturing to ensure product quality requirements are defined, implemented and maintained.
- Manage internal audit programs, supplier audits, and external customer/regulatory audits including preparation, execution, response management, and closure activities.
- Ensure Device History Records (DHRs), quality records, and documentation are complete, accurate, inspection ready, and maintained in accordance with document control requirements.
- Oversee supplier quality activities including supplier qualification, monitoring, risk assessment, corrective action and Approved Supplier List (ASL)
- Ensure training programs are established and maintained to support competency, compliance and effectiveness of personnel performing quality-related activities.
- Assist in investigations involving product nonconformance, escapes, complaints, audit findings, and process failures using structured problem-solving methodologies such as 5-Why, Fishbone and FMEA.
Education and Experience:- A minimum of a Bachelor's degree is required, preferably in a scientific discipline. Equivalent related experience may be accepted
- 5-10 years' hands-on experience with quality systems supporting medical device manufacturing. Experience with machined/mechanical components a strong plus
- 3-5 years management experience
- In depth working knowledge of FDA 21 CFR Part 820; Quality System Regulation
- Familiar with ISO 13485 Medical device directive
- ASQC and/or ASQE certification a plus
- Proficient with MS Office applications
- Six Sigma Black Belt or Green Belt training a plus
Job Knowledge, Skills and Abilities:- Must have strong leadership and decision-making skills with the ability to work constructively in difficult situations both internally and externally (with customers and suppliers).
- Strong verbal, writing, communication, and computer skills.
- Strong analytical and problem-solving skills with good experimental and documentation habits
- Strong multitasking skills with the ability to work in a highly dynamic environment
- Detail oriented with a high level of emphasis on accuracy and completeness
Physical Demands:- Light to moderate physical exertion required
- Regularly required to stand, reach and move about the facility
- Lifting/carrying Maximum lbs: 25
