Senior Engineer, Quality Assurance Engineering

Key Areas of Responsibility:
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.
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, 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.
Perform other related duties as assigned.

Work Schedule & On-Site Expectations
First shift
On site 4 days/week, 1 remote day (remote day will come later following full training)
Typical hours: 7:30 AM5/6 PM
No rigid 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 to 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 to 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
Experience in a regulated industry

Required Background
Engineering or science degree (BS)

Tools & Systems Used
TrackWise nonconformances, CAPAs, complaints
MasterControl document management
SAP order management, holds, manufacturing systems (SAP experience helpful but trainable)

Quality Tools & Concepts They Like to See
PPAP (nice to have)
Validation experience
DFMEA / PFMEA
Control Plans
Process Flow Diagrams
Ability to define requirements and collect objective evidence

Project overview and day-to-day activities:
This isnt an ask to support a project. This would be a universal player conducting Quality Engineering based work. Their day to 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 to bring in cross functional teams, driving with urgency to 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 also work with Operations to 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 also be brought into process improvements/validation reviews for internal efforts.

Spotlight Call Notes Below
Minimum Experience: 3%2B years
Reason for Opening: Backfill due to an unexpected departure; immediate need to support backlog.
Strong problem-solving and organizational skills in a fast-paced environment
Clear communicator who can effectively manage priorities and stakeholders
Highly detail-oriented and able to work independently
Ability to lead and collaborate with cross-functional teams
Strong root cause analysis experience, with formal RCA preferred
Manufacturing and formal validation experience strongly preferred
Ability to conduct detailed reviews of validation documentation, PPAPs, and supplier changes
Not a fit: Candidates whose quality experience is primarily limited to incoming inspection

Preferred Industry Background:
Medical Device: Strongest fit due to regulated environment and validation requirements
Aerospace: Strong transferable experience with regulated processes and validation
Biology/Lab: May be considered, but is a less direct fit

Interview Process
Format: One interview with the Hiring Manager
Preferred: Onsite when scheduling permits; Teams available as an alternative
Availability: Earlier in the day preferred; Friday may be easier. Unavailable Thursday. Next week is more likely for interviews.

Supplier Focus
Prioritize candidates with 3%2B years of quality/engineering experience and strong experience in root cause analysis, validation, manufacturing quality, and cross-functional leadership, ideally within medical device or aerospace environments.