Senior Quality Assurance Engineer

Job Description

Work closely with Operations and the business functions to ensure quality performance of product and processes.

Non-Conformances
- Collaborate with Internal cross-functional and Supplier teams to address top quality issues.

Owning identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise.

Support execution and analysis of manufacturing related complaint investigations and product field actions.

Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

Supplier Activities
- Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.

Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.

Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

Process Improvements/Validation
- Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.

Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

Participate in and potentially lead the creation and/or review of new or modified procedures.

Support the development and review of process and equipment validation/qualification and MSA of internal processes.

Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Required Education

Bachelor's Degree

Must Have Skills/Attributes

• Engineering
• Quality Assurance
• SAP Experience

Desired Experience/Skills

• Quality Engineering experience in a manufacturing or regulated industry environment (5+ yrs)
• Experience in investigating nonconformances, CAPAs, and quality issues (5+ yrs)
• Quality systems such as TrackWise, SAP, Mastercontrol (5+ yrs)
• Medical device experience (preferred, not required)
• Experience in a regulated industry
• PPAP (nice to have)
• Validation experience
• DFMEA / PFMEA Control Plans Process Flow Diagrams

Preferred Experience/Skills

• Naturally curious and investigative
• Strong root cause analysis experience
• Comfortable leading discussions and influencing stakeholders
• Able to work independently and collaboratively
• Strong communication skills, especially when explaining resolution plans
• Comfortable working in stressful, time-sensitive situations
• Medical device experience (preferred, not required)
• Experience in a regulated industry
• PPAP (nice to have)
• Validation experience
• DFMEA / PFMEA Control Plans Process Flow Diagrams

Benefits

For information and details on employment benefits offered with this position, please visit here.

Contact Information

If you have any questions/concerns, please contact our HR Department via our secure website.