Sr. Supplier Quality Engineer II

Sr. Supplier Quality Engineer II

Location: Aliso Viejo, California

Category: Professional Services

Salary: Apply for details

Country: United States

Employment: Direct Hire/Perm

Worksite: On-Site

Role Overview:

As a critical member of the Global Quality organization, the Sr. Supplier Quality Engineer II will support the oversight of suppliers/vendors utilized by in the development, manufacturing, and/or distribution of medical devices and pharmaceutical products. This person has primary responsibility for performing supplier/vendor assessments, on-site inspections, and monitoring performance of vendors/suppliers in accordance with the Supplier Quality Management program. This person will lead and drive assurance of Supplier Quality performance to ensure that suppliers meet all identified regulatory and specific requirements impacting component and/or product quality. Initiate, support, and lead, as applicable, the supplier quality related initiatives with suppliers to improve product quality and on-time delivery of contracted goods/services

Responsibilities

• Work with cross functional department to review and approve requests for new suppliers to determine the supplier risk level and supplier qualification requirements.

• Determine classification risk level and qualification requirements for new suppliers.

• Work with suppliers and legal department to create new or redline quality agreements and maintain quality agreements to support all the supplier’s quality requirement.

• Maintain “Approved Suppliers List” (ASL) information in Oracle regarding the part numbers and service types for suppliers.

• Submit and review changes to supplier classification, supplier risk level and supplier status.

• Take necessary actions, including issuing Supplier Corrective Action Requests) to improve supplier performance.

• Support maintenance of the Supplier Quality Records

• Supplier Assessment schedule development and execution, including leading on-site and or on-site supplier audits.

• Update supplier profiles or documentation as needed related to supplier changes.

• Lead supplier performance management by analyzing performing data, identifying opportunities for improvement, and driving action on suppliers.

• Drive resolution of Supplier Corrective Action Requests (SCARs).

• Ensure continuous improvement and optimization of Supplier management procedures and processes.

• Own the elimination of supplier product risk to improve reliability across the product lifecycle. Engage in Quality activities from concept through development and manufacturing to field use, with internal teams and suppliers.

• Ensure the execution of product and process requirements with suppliers. Define and improve such requirements.

• Work cross-functionally to ensure quality standards are being met. Facilitate smooth communication between the product team and suppliers.

• Participate in the evaluation and improvement of suppliers. Frequent local car and occasional domestic air travel to visit suppliers (up to 50%)

• Support the continuous improvement of the Quality Management System. Define and improve required documentation and activities.

• Support investigations, initiatives, and projects as needed, at the team or organization level.

Education

• – Bachelor’s Degree in Engineer Required

Experience

• 8+ years of relevant working experience Required Knowledge, Skills and Abilities

• Working understanding of 21CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971 requirements Required

• Strong knowledge of regulations applicable to pharmaceutical and medical device manufacturing. Experience in performing Quality System and supplier audits is highly desirable. Required

• ASQ certifications preferred. CQA, CBA, CQE, CSSBB Required

• Strong documentation skills, attention to detail and accuracy Required

• Strong written/oral communication skills Required

• Ability to work cooperatively and effectively in a team environment. Required

• Experience in Suppler Management with manufactured products. Required

• Experience with Quality Management Systems (QMS), Root Cause and Corrective Action. Required

• Comp $107-134K based on level/experience

• Equal Opportunity Employer

• We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

• Fraud Alert

• Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

• Share This Job

• Share on Linkedin

• Share on WhatsApp

• Share on Email

• Stay up to date with the

• latest opportunities

• Sign Up for Job Alerts Today →

• Related Jobs

• Associate Medical Director

Location

Remote, Massachusetts

Category: Medical Affairs

Type: Contract

Worksite: On-Site

Apply Now View Details

Senior Clinical Scientist

Location

Cambridge, Massachusetts

Category: Scientific

Type: Contract

Worksite: On-Site

Apply Now View Details

Associate Director, Clinical Safety

Location

Tokyo, Tokyo

Category: Pharmacovigilance

Type: Direct Hire/Perm

Worksite: On-Site

Apply Now View Details

APPLY NOW