Supplier Quality Engineer

3 weeks ago


Santa Rosa, United States NeilMed Pharmaceuticals Full time

Summary of Responsibilities:

Supplier Quality Engineer will work ON SITE at our Corporate facility located in Santa Rosa, CA. The ideal candidate has medical device and pharmaceutical experience and a demonstrated ability to address technical challenges with creative problem-solving techniques. In addition, the ideal candidate has a demonstrated ability to work cross-functionally with Operations, Supply Chain, and Regulatory partners with minimal supervision.


Key Responsibilities:

Conduct benchmarking studies to determine best practices/designs and future trends as required.

Work with purchasing and supplier on technical matters.

Lead inspection and testing of the samples and decide whether it meets the established criteria or not. If not, then advise the supplier on the required changes.

Lead the supplier approval process and complete all necessary documentation per quality system requirements.

Establish supplier audit plan and carry out supplier audits per pre-established schedule.

Support purchasing to provide product and component related necessary information in a timely manner.

Facilitate root cause analysis and supplier corrective actions requests for supplier related quality issues

Perform on-site and/or virtual supplier visits for root cause analysis and verification of correction actions of supplier quality issues.

Collate and evaluate supplier quality data to identify process improvement opportunities within the supply chain.

Work with the supplier directly, create correction action plans to address process failures.

Perform supplier evaluation in an established timeline and monitor approved supplier list.

Support manufacturing on supplier related quality issues.

Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system.

Update and maintain supplier scorecards.

Support new product launches to ensure that supplier quality meets the required standards.

Provide concise, complete and accurate documentation of inspection results relative to area of responsibility.

Participate in cross-functional teams in the development of new products or changes related to current products in meeting customer requirements as required.

Other duties as assigned


QUALIFICATION requirements (EXPERIENCE, TRAINING, SKILLS, EDUCATION)


KNOWLEDGE/EDUCATION


  • BS in Engineering or equivalent
  • Knowledge of QSR / ISO13485 / EN 46002 / MDR
  • Preferred green belt or six sigma

JOB EXPERIENCE

  • At least 5 to 7 years of experience.


SKILLS/COMPETENCIES


  • Knowledge of quality and business systems
  • Knowledge of measurement techniques
  • Understanding and interpretation of engineering drawings
  • Understanding manufacturing processes
  • Ability to work in a diverse and dynamic environment
  • Planning and prioritizing activities
  • Good communication and interpersonal skills
  • Listening, Negotiation and Analytical skills
  • Ability to present data effectively
  • Problem-solving skills
  • Team working skills
  • Understanding of cost and financial impacts
  • Audit skills
  • Statistical Knowledge
  • Communication, technical writing.
  • Ability to work under minimal supervision and independently.
  • Must be able to work in a timeline-driven environment.



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