Supplier Quality Engineer
Your role:
- Manage Supplier Quality Engineering related activities for purchased finished medical devices for the monitoring accessories business. Products include SpO2 sensors, NIPB cuffs, Temperature probes, ECG & patient cables, CO2 sensors, etc. Products are OEM and Contract Manufactured.
- Work with Development, Manufacturing, and External Suppliers to assess risks and define CTQs. Lead the Advanced Product Quality Planning (APQP) cross-functional team to provide the required deliverables in a timely manner.
- Work with suppliers to ensure all necessary quality activities are rigorously addressed during initial product release and change via APQP: process mapping, process FMEA, process control plan, process validation (IQ, OQ, PQ), GR&R, MSA, line release, ramp monitoring, etc. Ensure supplier test strategy aligns with quality goals. Support targeted and “at-risk” suppliers with new product introduction and facilitate from concept to launch whilst communicating and offering solutions for any potential risks identified.
- Focus on quality issue resolution via an 8-D based Supplier Corrective Action request process. Resolve quality issues via structured quality methods in order to ensure efficient and effective root cause analysis, and corrective / preventive actions that ensure there is no recurrence. Execute supplier audits, CAPA’s and monitor supplier metrics. Proactively collaborate with suppliers to identify and execute data driven continuous improvement projects.
You're the right fit if:
- BS Engineering degree and 8+ years total industry experience, 4+ in manufacturing of electro-mechanicalsystems/products/solutionsfor the medical, aerospace or automotive industries. CQE, six-sigma Black Belt or Green Belt preferred.
- Demonstrated knowledge of manufacturing processes for commodities such as sensors, cables, custom battery packs, mechanical parts (plastics, machined, sheet metal), cables, etc.
- Strong hands-on project management and teamwork skills with demonstrated ability to consistently establish and meet aggressive timelines. Demonstrated ability to build and maintain productive cross-functional and cross-organizational relationships on a global scale. Demonstrated ability to prioritize in a dynamic environment.
- Strong APQP knowledge and experience with all aspects of supplier quality management: qualityconcepts/tools/methods(e.g. FMEA, DOE, IQ/OQ/PQ, MSA, GRR, 8D, etc.), quality issue resolution and quality monitoring measures (use of statistical process control methodologies (CPk/PPk and data analysis is essential)
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
How we work together
This is an office role
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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The pay range for this position in Cambridge, MA is $89,000 – 145,000, Annually.
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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
within commuting distance to Cambridge, MA.