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Supplier Quality Engineer

2 months ago

Vista, United States Enovis Full time

Job Description:

At Enovis we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

Because that's how we change the lives of patients for the better. And that's how we create better together.

As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Supplier Quality Engineer

Reports To:

Manager, Quality Assurance

Location:

Vista, California | Onsite required

Job Title/High Level Position Summary:

We are looking for a talented and experienced Supplier Quality Engineer to join our team. The Supplier Quality Engineer (SQE) will implement and perform Supplier Quality Engineering activities at our company's manufacturing location. The SQE will provide a leadership quality role in the implementation of the Site Supplier Quality Assurance Program.

The ideal candidate will have an extensive knowledge of engineering and problem-solving principles and be responsible for a variety of complex activities related to designing, implementing, and maintaining quality assurance protocols and methods. The SQE will ensure external safety, quality, and compliance with the most complex company standards and government regulations.

Key Responsibilities:

  • Write and issue procedures to assure compliance with the current FDA QSR regulations, ISO standards, CMDR, and Medical Device Directive requirements; and to provide training to process owners related to Quality Management System requirements, as necessary.
  • Support New Supplier Approval process as Quality lead to ensure adherence to local and global work instructions.
  • Support maintenance of the Approved Supplier List.
  • Perform Supplier Evaluations by conducting remote performance and desktop reviews.
  • Conduct facility, product-specific & quality system audits for compliance to requirements and to verify supplier capabilities and quality.
  • Initiate and manage CAPAs that result from the audits.
  • Investigate supplier-caused product problems, drive root cause identification and corrective actions, and manage Supplier Corrective Actions, communicating and coordinating CAPA completion of suppliers.
  • Support Internal CAPA Program as required, including by example and not exclusion performing CAPA investigations and improvement implementation, verifying implementation and effectiveness of improvements.
  • Support Nonconforming Material investigation and review, maintain Agile NCMR data for supplier-related NCMRs.
  • Develop and present supplier metrics for review and track assignments and action items resulting from these meetings. Metrics may include supplier defective parts per million (DPPM) and yield trends, supplier product complaints, non-conforming material reports, audit non-conformance for Supplier Correction Action Requests (SCARs), supplier corrective actions, and supplier scorecard trends.
  • Coordinate Supplier Change notices.
  • Support Supplier Process validation activities.
  • Conduct internal audits, enter non-compliances into the Agile system and trend software, and follow up with process owners until CAPA is closed.
  • Assist in and support Notified Body Audits, FDA inspection.
  • Performs other duties as assigned by Management

Qualifications:

  • Bachelor's degree in science or engineering and 3 plus years of applicable experience (CQA or CQE certification preferred)
  • Bilingual Spanish/English required
  • Requires certification to perform audits. Certification may be obtained through successful completion of an auditor course, successful completion of CQA (Certified Quality Auditor) or on-the-job training by another qualified internal auditor.
  • Requires experience necessary to demonstrate the capability to carry out specialized technical/trade/craft procedures. May require regular use of speaking skills to discuss/explain semi-complex information or writing skills to communicate standard matters or procedures.
  • Requires experience in Medical Device engineering standards and concepts. Required knowledge of FDA/GMP, CMDR, MDR, MDSAP, and ISO quality standards.
  • Requires basic knowledge of manufacturing processes (and associated tools, instruments, and test equipment) to include inspection, machine shop technology, polish/grind, and clean room technology.
  • To perform this job successfully, an individual should know Microsoft Word, or equivalent word processing software, Excel, or equivalent spreadsheet software. Statistical analysis and database searches.
  • Competent working knowledge of US and International quality system regulations.
  • Proven project management skills.

"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale. We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short video and discover what creating better together means to us at Enovis:

Our Enovis Purpose, Values and Behaviors on Vimeo

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit www.enovis.com to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.