Senior Quality Engineer
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: North Haven • Colorado, Connecticut • 🇺🇸 United States
Visit company websiteSalary
💰 $96,800 - $145,200 per year
Job Level
Senior
About the role
- Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services
- Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems
- Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred
- Develop and prioritize an auditing schedule to ensure suppliers meet GMP and quality standards through regular audits
- Evaluate suppliers' internal functions to assess overall performance and provide feedback
- Manage Non-Conformance Material Reports (NCMRs) on materials-related quality issues and trends (Incoming, Production, Sterilization)
- Handle suppliers' change requests, including communication, project management via MAP Agile workflow, and regular reporting
- Manage the Approved Supplier List, including administrative work in MAP Agile
- Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management
- Improve suppliers' performance and reduce escapes to manufacturing
- Execute Process validation IQ/OQ/PQ and Master Validation Planning in new product development
- Knowledgeable in Statistical analysis (MSA, Capability, SPC)
- Support DFMEA and PFMEA activities
- Identification of critical to quality parameters and process controls in collaboration with designers and cross-functional team
- Design Transfer; translating design specifications into production specifications
- Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation
- Provide mentorship and coaching
Requirements
- Bachelor’s degree in engineering or related field
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
- Experience with PCBA suppliers and validation of PCBA test and manufacturing processes strongly preferred
- Medical device manufacturing industry experience, preferably ISO 13485
- Lead auditor experience
- Hands-on experience with SAP, Trackwise, Agile change management
- Ability to manage tasks and projects under tight deadlines with a sense of urgency
- Strong communication and presentation skills, with the ability to confidently address external audiences and high-level leadership
- Comfortable navigating through complex networks with diplomatic approaches and reporting to a flattened organization
- Equipped with sophisticated problem-solving methodologies (Lean/Sigma) and great attention to detail to fit for fast-accurate action-driven environments
- Engage in changes and advocate for inclusion/diversity
- Experience with materials and manufacturing processes such as PCBAs, MIM, nitinol, cables, crimping, laser welding, automated functional testing DRM or DFSS
- Knowledge of GD&T
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Simple Steps (global well-being program)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
PCBA validationProcess validationStatistical analysisTechnical writingProject managementGMP standardsDFMEAPFMEAGD&TMaster Validation Planning
Soft skills
Communication skillsPresentation skillsProblem-solvingAttention to detailMentorshipCoachingProject management under tight deadlinesDiplomatic approachAdvocacy for inclusion/diversityCollaboration
Certifications
Bachelor’s degree in engineeringLead auditor certificationISO 13485 knowledge