Sr. Supplier Quality Engineer - Injection Molding

Yoh Services LLC; San Diego (CA); On-site; USD 116,000 - 145,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly pay

Job summary

Yoh is seeking a Senior Supplier Quality Engineer in San Diego to lead supplier quality on cross-functional teams. You will develop material specifications, manage supplier performance, conduct audits, and drive CAPAs to ensure GMP-compliant quality for medical devices.

Ideal candidates have 8+ years in QA with supplier management, experience with injection molding and plastics, and strong analytical and documentation skills. Direct Hire, onsite in San Diego, $116k–$145k DOE.

Qualifications

• Bachelor's degree in a related scientific or engineering discipline.
• Eight+ years of QA experience with supplier interactions.
• Five+ years of supplier management experience.
• Experience with injection molding and plastics.
• Knowledge of GMP processes and supplier quality audits.
• Experience with supplier qualification, performance management, SCARs, CAPA, and change control.

Responsibilities

• Serve as primary quality lead on cross-functional teams for new materials and supplier-related changes.
• Develop and execute qualification programs for new materials and suppliers using a risk-based approach.
• Evaluate and monitor supplier risk levels to meet quality requirements.
• Lead annual supplier audit program and ensure timely completion of audits.
• Conduct internal and external supplier audits and manage audit reports and nonconformances.
• Lead investigations of material and supplier-related issues and develop CAPA.

Skills

Supplier management

Quality Assurance

Audits

CAPA

Change control

GMP

SCARs

Documentation

Injection molding

Materials

Risk analysis

Statistical methods

SAP

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.

Ideal Candidate

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?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• 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.

Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.