Work Arrangement: Hybrid – 4 days onsite, 1 day remote (remote day available after completion of training)
Position Overview
We are seeking an experienced Senior Quality Assurance Engineer to support manufacturing operations and supplier quality activities within a fast-paced, regulated manufacturing environment.
This role will play a key part in maintaining product and process quality by investigating nonconformances, managing corrective and preventive actions (CAPAs), conducting root cause analysis, and driving continuous improvement initiatives. The ideal candidate is a proactive problem-solver who can independently manage multiple quality issues, lead cross-functional discussions, and work with urgency to resolve manufacturing and supplier-related challenges.
Key Responsibilities
Quality Systems & Nonconformance Management
- Own and manage internal and supplier-related Nonconformance (NC) and Corrective and Preventive Action (CAPA) records, ensuring timely investigation, documentation, and closure within TrackWise.
- Lead root cause investigations and coordinate corrective actions with cross-functional teams and suppliers.
- Investigate and disposition nonconforming products through the Material Review Board (MRB) process.
- Support manufacturing-related complaint investigations and product field actions.
- Lead problem-solving discussions and coordinate containment activities, particularly during production disruptions or line-down situations.
Supplier Quality Management
- Partner with suppliers to investigate quality issues and drive resolution, escalating Supplier Corrective Action Requests (SCARs) when necessary.
- Review and manage Supplier Initiated Change Requests (SICRs), coordinating cross-functional assessments and approvals.
- Evaluate supplier changes and oversee Production Part Approval Process (PPAP) activities.
- Support manufacturing transfers between facilities and identify opportunities for supplier part certification.
Process Improvement & Validation
- Support continuous improvement initiatives focused on manufacturing efficiency, product quality, and production throughput.
- Review and support process and equipment validation and qualification activities, including Measurement System Analysis (MSA).
- Evaluate internal and supplier-proposed process changes and assess their potential impact on product quality.
- Review validation protocols, reports, procedures, work instructions, change orders, and other quality documentation.
- Maintain and analyze quality performance metrics and KPIs, identifying trends and implementing appropriate improvement actions.
- Participate in the development and revision of quality procedures and manufacturing processes.
Required Qualifications
- Bachelor's degree in Engineering or a related scientific discipline.
- Minimum of 3 years of quality engineering or quality assurance experience in a manufacturing or regulated environment.
- Strong experience with root cause analysis, nonconformance investigations, and corrective/preventive actions.
- Experience collaborating with cross-functional teams to resolve manufacturing and supplier quality issues.
- Ability to independently manage multiple priorities in a fast-paced, time-sensitive environment.
- Excellent communication, organizational, analytical, and problem-solving skills.
Preferred Qualifications
- Experience in the medical device industry or another highly regulated manufacturing environment.
- Manufacturing floor experience and familiarity with production operations.
- Experience with process and equipment validation, qualification, and validation documentation.
- Familiarity with PPAP, SCAR, DFMEA, PFMEA, Control Plans, and Process Flow Diagrams.
- Experience reviewing supplier changes and assessing quality and validation requirements.
- Knowledge of quality management systems and document control processes.
- Experience with TrackWise, MasterControl, and SAP.
- First shift.
- Typically 7:30 AM to 5:00–6:00 PM, with flexibility depending on business and production needs.
- Four days onsite and one remote day per week. Remote work will be available after completion of initial training.
- Frequent interaction with manufacturing operators, engineering, regulatory, compliance, and supplier teams.
- Fast-paced manufacturing environment requiring flexibility, sound judgment, and the ability to respond quickly to emerging quality issues.
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