Supplier Quality Engineer (Medical Devices)

We are seeking a Supplier Quality Engineer to work on a team at our client site in Irvine, CA. This role is W2 hourly with Roth Staffing. No 3rd party candidates can be submitted to this role.

Role Description:

The Supplier Quality Engineer II will directly support the design and development teams in qualifying critical materials and suppliers in support of launching innovative & life-saving medical devices. This individual will facilitate compliance to applicable internal and external requirements. You will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success. This role will work in close partnership with R&D, Operations, Quality, Sourcing, and RA.

Job Function:

* Responsible for ensuring compliance with all Federal, State, local, and company regulations, policies, and procedures.

* Works with suppliers to ensure quality system and supplied product requirements are understood and successfully met.

* Responsible for helping define supplier qualification requirements for OEM and custom materials and devices.

* Ensures validation methods of critical suppliers and incoming quality control are aligned with device risk, internal requirements, international standards, global regulations, and Industry best practices.

* Supports completion of Design Development File requirements applicable to supplied components, subassemblies, devices, and services.

* Supports risk management and validation activities with suppliers.

* Develops inspection methods and procedures for receiving inspection and/or supplier final release.

* Executes test method validation activities for receiving inspection and/or supplier final release.

* Knowledge of NCR & CAPA elements is preferred.

* Assesses non-conformances and leads closure of SCARs as needed.

Required Education / Qualifications:

* Bachelor's degree in Engineering or Scientific field with at least 2 years of experience with supplier quality, manufacturing, or quality engineering functions

* Highly regulated industry experience

Preferred Qualifications:

* Engineering degree

* Experience with supplier quality engineering activities, including external supplier vendor audits

* Effective problem-solving techniques and experience with technical tools (i.e. Root Cause Analysis, dFMEA process, Gage R&R, etc.)

* Proficient understanding of Design Controls, test method development & validation, and risk management.

* Conduct effective root cause investigations; assessment of corrective action strategies; and effectiveness as applied to NCRs and SCARs

* Experience with class II and class III medical devices

* Medical device, pharma, biotech or other regulated industry experience

* Demonstrated ability to apply statistical quality engineering tools

* Ability to read and interpret drawings

* Knowledge and understanding of FDA and international regulatory standards for medical devices is preferred.

* Ability to manage multiple and frequently changing projects and priorities.

* Ability to work independently without close supervision

* Effective communication and conflict resolution skills

* Highly developed time management, communication, and documentation skills

* Strong communication and organizational skills to effectively manage and get results with external suppliers

* Six Sigma Black Belt/LEAN Manufacturing experience

* ASQ Certified Quality Engineer or ASQ/BSI Certified Quality Auditor

* Domestic and international travel up to 25%

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.