Senior Engineer, Quality Assurance Engineering

Job Description

Job Description

Comment:
Key Areas of Responsibility:
Work closely with Operations and the business functions ensure quality performance of product and processes.

Non-Conformances
Collaborate with Internal cross-functional and Supplier teams address top quality issues.
Own 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, Track wise.
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 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.
Perform other related duties as assigned.

Additional Job Details:
Work Schedule & On-Site Expectations
First shift
On site 4 days/week, 1 remote day
Typical hours: 7:30 AM5/6 PM
Unrigid schedule; flexibility based on workflow Role Overview the Quality Engineer supports both:
Manufacturing operations, and

Suppliers Key Responsibilities Include:
Investigating nonconformances, CAPAs, and quality issues
Performing root cause analysis
Leading cross-functional problem-solving huddles
Driving process improvements (efficiency, throughput, new equipment) This is a fast-paced, high-pressure environment, where multiple quality issues can arise at once. The QE must be able pivot quickly, provide direction, and help get production back up and running.

Key Skills & Traits Needed
Naturally curious and investigative
Strong root cause analysis experience
Comfortable leading discussions and influencing stakeholders
Able work independently and collaboratively
Strong communication skills, especially when explaining resolution plans
Comfortable working in stressful, time-sensitive situations Manufacturing & Stakeholder Interaction

Frequent Interaction with:
Manufacturing operators (on the line and at their desk)
Engineering Regulatory
Compliance
Suppliers
Experience on a manufacturing floor is highly desirable (but not required) Documentation & Validation Work the QE will review and/or support:
Validation protocols and reports Process and equipment validation
Label reviews
Change orders
Documentation reviews the team has a broad scope of influence across quality systems and operations. Preferred (Not Required) Background
Medical device experience (preferred, not required)
Experience in a regulated industry
Engineering or science degree (BS preferred) Example of a successful prior hire:
Background in bioscience/lab work
Direct manufacturing experience initially
Strong technical thinking, stakeholder management, and execution speed
Successfully translated lab skills in manufacturing quality work Tools & Systems Used
Track Wise nonconformances, CAPAs, complaints
Master Control document management
SAP order management, holds, manufacturing systems (SAP experience helpful but trainable) Quality Tools & Concepts They Like see
PPAP (nice have)
Validation experience
DFMEA / PFMEA
Control Plans
Process Flow Diagrams
Ability define requirements and collect objective evidence Can you give us an overview of the project this resource would be working on and what the day-to-day activities would look like This isnt an ask support a project. This would be a universal player conducting Quality Engineering based work. Their day day will likely vary, depending on what is going on in the manufacturing space and business needs. They will own NCs and potentially CAPAs, needing bring in cross functional teams, driving with urgency resolve the issue. They will contain nonconforming product and work with the Operations team when a line down situation occurs, which is a fast-paced environment. They will al work with Operations ensure quality performances of products and processes. They will own PPAPs, for supplier changes, which can be an urgent change or ones that are less urgent. They may als be brought in tprocess improvements/validation reviews for internal efforts.