Sr. Supplier Quality Engineer - Injection Molding

Yoh, A Day & Zimmermann Company; San Diego (CA); On-site; USD 116,000 - 145,000; Full time

Benefits offered by this job

Medical benefits

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Certification and training

Job summary

Yoh is seeking a Senior Supplier Quality Engineer for our client in San Diego. You will serve as a primary quality lead on cross-functional teams supporting new materials, supplier qualifications, and supplier-related changes.

The Senior SQE will develop and maintain material specifications, manage supplier quality and performance, conduct supplier audits, lead investigations and CAPA, and ensure compliance with internal and external quality requirements and regulations.

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, or biomedical engineering.
• Eight years of relevant Quality Assurance experience.
• Five years of supplier management experience.
• Experience with injection molding and plastics.
• GMP knowledge and experience with quality systems.
• Experience with supplier audits and Quality System audits.
• Experience with supplier qualification, SCARs, CAPA, and change control.
• Experience with electronic document management systems.
• Strong technical writing and risk assessment skills.
• SAP experience is a plus.
• Knowledge of materials, formulations, and manufacturing processes.
• Analytical skills with statistics and data trends.
• Strong project management and organizational skills.
• Excellent cross-functional communication skills.

Responsibilities

• Serve as the primary quality lead on cross-functional teams for materials, supplier qualifications, supplier changes, and supplier management activities.
• Develop and execute qualification programs for new materials and suppliers using a risk-based approach.
• Evaluate and monitor supplier risk levels to ensure materials meet quality requirements.
• Lead supplier audits and annual audit programs with risk-based planning.
• Independently conduct supplier audits and manage nonconformances and corrective actions.
• Lead investigations of material and supplier-related issues and develop CAPA plans.
• Manage SCARs including investigation and effectiveness assessment.
• Review and monitor supplier qualification and performance scorecards with timely follow-ups.
• Collaborate with suppliers to review and approve quality documentation and improvement plans.
• Develop, monitor, and trend Supplier Quality System metrics for continuous improvement.
• Create and approve supplier quality procedures and documentation for compliance.
• Review supplier Quality Agreements to support qualification.
• Author and approve raw material specifications for supplier qualification.
• Ensure material specifications are developed and maintained.
• Lead meetings on critical supplier quality issues and ensure action items are completed.
• Assess supplier change notifications and advise on impact to product quality and QMS.
• Serve as SME for supplier-related change control processes.
• Provide QA representation on projects involving new materials and supplier management.
• Develop and support Quality System and training programs for employees.
• Train and mentor team members within and outside Supplier Quality.
• Host third-party audits including FDA inspections and regulatory reviews.
• Apply statistical methods to investigations, supplier performance, and continuous improvement activities.

Skills

Quality Assurance

Supplier management

GMP knowledge

Audits

Root cause analysis

CAPA

Change control

Documentation & SOPs

Data analysis

Project management

Education

Bachelor's degree in Biology, Chemistry, Biochemistry, Biomedical Engineering

Tools

SAP

Job description

Yoh is seeking a Senior Supplier Quality Engineer for our client in San Diego. In this role, you will serve as a primary quality lead on cross-functional teams supporting new materials, supplier qualifications, and supplier-related changes. The Senior Supplier Quality Engineer will be responsible for developing and maintaining material specifications, managing supplier quality and performance, conducting supplier audits, leading investigations and corrective actions, and ensuring compliance with internal and external quality requirements, standards, and regulations.

The ideal candidate will bring extensive Quality Assurance and Supplier Management experience and must have experience with injection molding and plastics.

Industry: Medical Device Manufacturing

Location: Onsite

Compensation: $116,000 - 145,000 DOE

Type: Direct Hire

Job Functions

• Serve as the primary Quality lead on cross-functional teams supporting new materials, supplier qualifications, supplier changes, and supplier management activities.
• Develop and execute qualification programs for new materials and suppliers using a risk-based approach.
• Evaluate and monitor supplier risk levels to ensure suppliers and materials meet company quality requirements.
• Develop and execute the annual supplier audit program using a risk-based approach and provide guidance to ensure successful completion.
• Independently conduct internal and external supplier audits, approve audit reports, and ensure associated nonconformances and corrective actions are appropriately addressed.
• Lead investigations of low-, medium-, and high-risk material and supplier-related issues, determine root cause, and develop appropriate corrective and preventive action plans.
• Manage Supplier Corrective Action Requests (SCARs), including communication of nonconformances, investigation, root cause analysis, corrective action, and effectiveness assessment.
• Review, approve, and monitor supplier qualification and performance scorecards and ensure follow‑up actions are completed within established timelines.
• Partner with suppliers to review and approve required quality documentation, including supplier questionnaires and improvement plans.
• Develop, monitor, and trend Supplier Quality System metrics to identify opportunities for continuous improvement.
• Create, review, and approve Supplier Quality procedures and documentation to ensure compliance with company requirements and applicable regulations.
• Review and assess supplier Quality Agreements to support timely supplier qualification.
• Independently author, review, and approve raw material specifications to support supplier and material qualification.
• Ensure appropriate material specifications are developed, maintained, reviewed, and approved.
• Lead critical supplier quality issues and stakeholder meetings, document meeting outcomes, and ensure timely completion of action items.
• Assess supplier change notifications and provide technical recommendations regarding potential impacts to product quality and the Quality Management System.
• Serve as a Subject Matter Expert (SME) for supplier‑related change control processes and monitor implementation of approved changes.
• Provide Quality Assurance representation on projects involving new materials, material changes, and supplier management.
• Develop and support Quality System and procedural training programs for employees.
• Train and mentor team members within and outside of the Supplier Quality organization.
• Host third‑party audits conducted by regulatory agencies, notified bodies, and business partners, including FDA inspections.
• Apply appropriate statistical methods and data analysis techniques to investigations, corrective actions, supplier performance, and continuous improvement activities.

Education, Licensure and/or Experience

• Bachelor's degree in Biology, Chemistry, Biochemistry, Biomedical Engineering, or a related scientific or engineering discipline required.
• Minimum of eight (8) years of relevant Quality Assurance experience.
• Minimum of five (5) years of Supplier Management experience.
• Experience with injection molding and plastics is required, including direct technical, maintenance, and/or quality experience.
• Demonstrated knowledge and experience with Good Manufacturing Practices (GMP) processes and procedures.
• Previous experience conducting and supporting supplier and Quality System audits.
• Experience with supplier qualification, supplier performance management, SCARs, root cause investigations, CAPA, and change control.
• Prior experience working with an electronic document management system required.
• Technical writing, trend analysis, and project leadership experience preferred.
• Experience implementing process improvements and analyzing quality trends is preferred.
• SAP experience is a plus.
• Strong technical writing skills with demonstrated ability to independently develop SOPs, forms, technical assessments, and risk assessments.
• Strong knowledge of materials, formulations, and manufacturing processes.
• Strong analytical skills with the ability to analyze and trend data using statistical methods and software.
• Excellent project management and organizational skills with the ability to manage multiple priorities and competing deadlines.
• Excellent written, verbal, and presentation skills with the ability to communicate effectively across all levels of a cross‑functional organization.
• Proficiency with Microsoft Office Suite.
• Demonstrated ability to work collaboratively with internal teams and external suppliers to develop and implement sustainable solutions.
• Ability to train, mentor, and provide technical guidance to others.

Physical Job Requirements

• Office, manufacturing, and supplier‑facing work environment.
• Regular use of a computer, keyboard, mouse, telephone, and other standard office equipment.
• May require extended periods of sitting, standing, or walking while supporting manufacturing activities, audits, and supplier quality initiatives.
• Must be able to review detailed technical documentation, specifications, quality records, and manufacturing data.
• May require travel to supplier locations or other company facilities to conduct audits and support supplier quality activities.

Estimated Min Rate: $116000.00

Estimated Max Rate: $145000.00

What’s In It for You?

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Please see our Candidate Privacy Notice: https://www.yoh.com/privacy-notice