Senior Quality Engineer
Position Overview
We are seeking a highly motivated Senior Quality Engineer to support manufacturing operations and supplier quality activities in a fast-paced, regulated environment. This individual will play a critical role in ensuring the quality performance of products and processes through investigation, root cause analysis, corrective action management, supplier collaboration, process improvement, and validation activities.

The ideal candidate is naturally curious, highly analytical, and thrives in dynamic manufacturing environments where urgency, problem-solving, and cross-functional collaboration are essential.

Work Schedule & Location

• First Shift
• On-site four (4) days per week, one (1) remote day
• Typical hours: 7:30 AM - 5:00/6:00 PM
• Flexible schedule based on workflow and business needs

Key Responsibilities
Quality Systems & Non-Conformance Management

• Partner closely with Operations and business functions to ensure quality performance of products and processes.
• Collaborate with internal cross-functional teams and suppliers to address top quality issues.
• Own and manage internal and supplier-driven Non-Conformance (NC) and Corrective and Preventive Action (CAPA) records.
• Drive timely processing and closure of NC and CAPA records within TrackWise.
• Support execution and analysis of manufacturing-related complaint investigations and product field actions.
• Investigate and disposition non-conforming product through MRB processes and issue NCs as appropriate.
• Conduct root cause investigations and lead cross-functional problem-solving efforts.

Supplier Quality Activities

• Communicate and collaborate with suppliers regarding non-conformances and quality concerns.
• Escalate and manage Supplier Corrective Action Requests (SCARs) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs), coordinating cross-functional assessments and approvals.
• Support manufacturing transfers between plants and facilities while ensuring appropriate quality oversight.
• Partner with stakeholders to identify and implement supplier part certification opportunities.
• Own Production Part Approval Process (PPAP) activities related to supplier changes.

Process Improvement & Validation

• Support development and continuous improvement of manufacturing and distribution processes.
• Assess and qualify internal and supplier-driven change management activities.
• Participate in and potentially lead the creation, revision, and review of procedures.
• Support development, execution, and review of process and equipment validation activities.
• Assist with qualification activities and Measurement System Analysis (MSA).
• Maintain and analyze quality performance metrics and KPIs, identify trends, and drive appropriate actions.
• Support process improvements focused on efficiency, throughput, equipment implementation, and overall product quality.

Documentation & Compliance

• Review and support:
  • Validation protocols and reports
  • Process and equipment validation activities
  • Label reviews
  • Change orders
  • Documentation reviews
• Ensure quality documentation complies with internal and regulatory requirements.

Day-to-Day Responsibilities
This is not a project-specific role. The Senior Quality Engineer serves as a versatile quality resource supporting manufacturing operations and business priorities as needs arise.
Daily responsibilities may include:

• Managing Non-Conformances and CAPAs
• Containing and dispositioning non-conforming product
• Supporting line-down situations and helping restore production
• Leading cross-functional quality investigations
• Collaborating with Operations to improve product and process quality
• Managing supplier-related quality changes and PPAP activities
• Participating in validation reviews and process improvement initiatives

The role requires the ability to balance multiple priorities while maintaining urgency and delivering effective solutions.

Cross-Functional Collaboration
This position regularly interacts with:

• Manufacturing Operators
• Operations Leadership
• Engineering
• Regulatory Affairs
• Compliance
• Suppliers
• Quality and Validation Teams

Required Skills & Competencies

• Strong root cause analysis and problem-solving abilities
• Investigative and detail-oriented mindset
• Ability to lead discussions and influence stakeholders across functions
• Strong verbal and written communication skills
• Ability to work independently and collaboratively
• Comfortable operating in fast-paced, high-pressure environments
• Ability to prioritize and manage multiple quality issues simultaneously

Preferred Qualifications

• Bachelor's degree in Engineering, Science, or a related discipline preferred
• Experience within a regulated industry
• Medical device industry experience preferred but not required
• Manufacturing floor experience highly desirable

Preferred Tools & Systems Experience

• TrackWise (Non-Conformances, CAPAs, Complaints)
• MasterControl (Document Management)
• SAP (Manufacturing, Order Management, Product Holds)

Preferred Quality Tools & Methodologies

• Production Part Approval Process (PPAP)
• Validation and qualification activities
• DFMEA / PFMEA
• Control Plans
• Process Flow Diagrams
• Requirements definition and objective evidence collection

This role offers broad exposure across quality systems, manufacturing operations, supplier quality, process improvement, and validation activities, making it an excellent opportunity for an experienced Quality Engineer seeking a highly visible and impactful position.