Role: Supplier Development Quality Engineer
Location: Scarborough, ME - 04074
Duration: 4 Months
Shift Timings: 8 AM to 5 PM (1st Shift)
Job Description
Role Overview:
The Supplier Quality Engineer ensures that all materials, products, and services received meet quality standards, impacting the final product's quality. This role involves working with purchasing, engineering, and other teams to maintain supplier quality and manage related processes.
Key Responsibilities
- Collaborate with Purchasing and Engineering teams to maintain supplier quality.
- Respond to internal and external supplier quality requests.
- Manage supplier changes and review their validation protocols.
- Conduct product inspections, capability studies, and resolve quality issues.
- Oversee the Supplier Corrective Action process and drive supplier improvements.
- Utilize metrics to assess supplier performance and develop improvement plans.
- Perform external audits as needed.
- Continuously improve quality systems and processes.
Qualifications
- Bachelor’s degree in Engineering, Manufacturing, Biology, or a related field (or equivalent experience).
- 2+ years of experience in the medical device industry, preferably in Quality or Supplier Engineering.
- Proficiency in Microsoft Office (Word, PowerPoint, Excel).
- Familiarity with relevant regulations (e.g., QSR’s, ISO 13485).
- Strong attention to detail, organizational skills, and ability to prioritize tasks.
- Excellent documentation, technical writing, and communication skills.
- Ability to work independently and adapt to changing priorities.
Preferred Skills
- Knowledge of federal regulations like 21 CFR Part 11.
- Strong interpersonal skills for maintaining effective working relationships.
