Senior Supplier Quality Engineer

Location: Bedford, MA

Position Scope:

The Supplier Quality Engineer (SQE) is responsible for the establishment of processes that enable realization of a zero-defect philosophy to our patients/customers for supplied material by overseeing and owning the supplier program.

Strategic Focus Areas:

The SQE will be responsible for the development and control of suppliers and contract manufacturers (CM).  The SQE has direct accountability to ensure that all material used in the fabrication and release of medical devices meets specification.  The SQE will drive continuous improvement for supplier quality processes to increase compliance and efficiency.  Additionally, they will collaborate with all functions to understand business/project requirements to execute improvement strategies for supplier quality performance.

Specific Tactical Responsibilities:

  • Interface directly with suppliers and CMs to develop and implement product and/or process controls required so that supplied material meets all design output requirements.
    • Full engagement and ownership in resolving supplier quality issues and dispositioning nonconforming materials using Supplier Nonconforming Material Reports and the Supplier Corrective Action Process.
    • Process requests for the onboarding of suppliers.
    • Perform/coordinate Supplier audits (Quality System and/or Product Quality based) and follow up on their results.
    • Track, analyze, and report on supplier performance metrics to stakeholders along with recommendations for tactical and strategic improvements.
    • Actively drive the assessment and improvement of quality system processes with emphasis on supplier development/quality.
    • Provide input to incoming inspection requirements based on supplier assessments and product process controls for controlling risk.
    • Other duties as assigned.

Job Complexity:

The Supplier Quality Engineer works on complex issues requiring analysis and use in-depth evaluation of factors.

Supervisory Responsibilities:

None

Required Qualifications:

  • Bachelor’s degree in Engineering or related field (or equivalent experience).
  • Minimum of 3-5 years of related experience in the medical device, biotech, or pharmaceutical industry.
  • Strong understanding of medical device regulations and standards, including QSR (21 CFR Part 820), Quality Management Systems (ISO 13485), and EU MDR (2017/745).
  • Lead Auditor Certification from accredited organization (preferably ISO 13485).
  • Versed in application of ISO 14971 with regards to FMEAs, Verification/Validation, and Risk Management.
  • Knowledge of statistical techniques as it applies to product development and development of production processes.
  • Problem solving ability, strong analytical skills, and diplomacy required.
  • Strong oral and written communication skills.
  • Self-motivated and ability to manage time working on multiple projects simultaneously.
  • Must be able to communicate appropriately and adequately to all levels of the organization in both individual and group settings.
  • Competency in MS office applications.

Desired Experience, Knowledge, and Skills:

  • Project Management (conducting status meetings, project reporting, etc) is a plus.
  • Experience with SAP preferred.
  • Experience with MasterControl preferred.

Travel:

May include up to 25% travel (including US and OUS).

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We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.

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