Job Title:

Quality Engineer Location:

Pacheco, CA Duration:

12 - 18 Months 1.0 Overview The Quality Engineer ETW (External Temporary Worker) role is responsible for BioCare/Client integration activities, including BioCare QMS certification maintenance, integration of BioCare into the Client QMS, IVDR and DHF remediation activities, inspection readiness support, and quality support for potential manufacturing and testing transfers. This role serves as an integration-focused quality resource providing governance, coordination, risk identification, remediation oversight, and escalation support to facilitate successful integration while maintaining regulatory compliance and business continuity. The QE will support execution of the BioCare integration and IVDR plans, achievement of key milestones, quality system harmonization activities, remediation programs, and readiness actions required to sustain compliant product supply through the transition period. 2.0 Essential Duties & Responsibilities Integration Quality Support for BioCare transition activities. Lead and coordinate quality integration workstreams and cross-functional integration projects. Support inspection readiness, audit preparation, and certification maintenance activities. Coordinate IVDR, DHF, CAPA, and QMS harmonization and remediation efforts. Develop and monitor integration metrics, risks, dependencies, and milestone progress. Maintain site metrics, responsible for site QMR and data interpretation with Sr. Leadership Support integration governance reviews and escalate significant quality or compliance risks. Confirm compliance of quality processes and documentation and establish a risk-based remediation program. Oversee development and implementation of relevant Quality Plans. Collaborate with Client Global Quality Leadership to support compliance and certification requirements. May also support daily operations such as general QA support, SOP review and approval, document review and approval, product logistics, batch record review, product investigations and inspection, assist in audits, coach and mentor, support NCRs, CAPAs, training, equipment qualifications, rework activities, and trending reports. 3.0 Education and/or Experience Education

•

Science or Engineering:

BS/MS/PhD or equivalent industry experience Experience Minimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodies Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR. Operations or Quality Experience in Medical Device Manufacturing FDA, and EU regulated work experiences desired Fluency with Six Sigma and/or Lean Manufacturing desired 4.0 Essential Skills Problem solver, root cause analysis methodology Process oriented mindset; data and continuous improvement orientation Able to work well in complex environment Good communicator Self-starting, self-reliant, courage of convictions International working experience and willingness to travel globally Proficient in written and spoken English Consistently work independently, make QA decisions without requiring supervision/coaching Demonstrates technical understanding of manufacturing process Provides compliant solutions to complex problems Able to Coach & Mentor less experienced

Professionals Pay:

$50.00 - $55.00 per hour Expected hours: 40.0 per week Application Question(s): Do you have experience in Medical Devices Manufacturing/Production Environment Experience with ISO Standards, GxP, QSR and FDA/EU regulations No. of years of experience as Quality Engineer not Software QA.

Work Location:

In person