Job Title : Supplier Quality Engineer
Location : Durham, NC
Duration : 12 months
Work days/hours: M - F 8am - 5pm
This position supports all efforts in developing and management for all Durham, NC facility. Primary responsibility for this position includes ensuring suppliers are compliant with BD standards and applicable US & global regulatory requirements as well as ensuring supplier has capacity and capability to meet BD demand. This position is accountable to provide leadership, development and coaching to suppliers as well as internal Supplier Quality Engineers.
Minimum Experience:
1. Bachelor's degree in an engineering discipline is required
2. A minimum of 5 year’s total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
3. Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
4. Lead Auditor certification is required
5. CAPA experience- Candidate must have worked and performed root cause analysis.
6. Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
7. Demonstrated knowledge of the Quality Engineering body of knowledge is required
8. Good communication and strong writing skills are required
9. Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.
10. ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
11. Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required
12. Candidate must be able to work autonomously and independently
13. Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1