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12584BR

Title:

Sr. Engineer, Supplier Quality

Job Description:

Responsible for supporting programs that reduce overall costs and improve supplier performance. Organize and report key supplier performance metrics to the Quality organization and other departments. Perform supplier audits to evaluate quality systems, process, services, and supplier capabilities. Assist with Material Review Board (MRB) process to resolve issues with supplier related components and services. Drive supplier root cause analysis and corrective action process to prevent recurrence of quality issues. Job duties:

+ Perform supplier risk assessment and participate in supplier selection to evaluate quality systems, processes, and services of suppliers.

+ Oversee supplier monitoring, Supplier Corrective Action Request (SCARs) and supplier related Non-Conformance Reports (NCRs), purchased part assessment, and evaluate impact of supplier change requests.

+ Assist with management of approved suppliers, via the Approved Supplier List (ASL).

+ Participate in the MRB process to drive supplier quality improvement, as required.

+ Execute (SCAR); review supplier quality performance and escalate based on risk, where needed.

+ Work with R&D, Operations and Procurement to ensure compliance for materials/components & services.

+ Support regulatory compliance gaps at suppliers (e.g. supplier quality system and process development activities).

+ Support supplier improvement programs, where needed.

+ Perform additional responsibilities as assigned.

Auto req ID:

12584BR

Location:

Aliso Viejo, California, USA

Department Name:

327-Indirect Manufacturing-Process Engineering

Qualifications:

1. Bachelor’s Degree in Engineering or a related science discipline.

2. Minimum of four (4) years of total supplier quality experience in a medical device or a pharmaceuticals manufacturing environment.

3. Strong written and verbal communication skills.

4. Working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 9001, ISO13485, QSR, MDD.

5. Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA, 5 WHYs etc.

6. Audit experience in quality assurance activities for medical device and drug products.

7. Experience with Root Cause Analysis, Corrective and Preventive Action methods.

8. Experience with process validations.

9. Proficient with MS Word, Excel, Outlook, and Teams.

Desired Qualifications

1. Good stakeholder management skills (Procurement, Q&R, R&D).

2. Project management experience.

External-Facing Title:

Sr. Engineer, Supplier Quality

Posting Country:

US - United States

Salary Range:

$100,000 - $131,000 (Compensation may be higher/lower based on experience, education and skill sets)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.