Supplier Quality Engineer

Burke Porter, an Ascential Technologies Brand•San Diego, CA

11d•$95,000 - $125,000•Onsite

About The Position

Ascential Medical and Life Sciences is a leader in delivering precision engineering and automation solutions for medical devices, diagnostics, and life sciences. We are looking for a Supplier Quality Engineer to join our multidisciplinary team, contributing to cutting-edge projects that drive innovation in healthcare and diagnostics. The Supplier Quality Engineer (SQE) is a critical role responsible for establishing, implementing, and maintaining robust supplier quality management processes within our CDMO operations. This position directly supports the organization's strategic objectives by: 1. Closing significant supplier quality gaps identified as major risks during multiple audits (client audits, BSI audits, and internal audits). 2. Rebuilding supplier quality oversight capabilities lost through attrition and organizational restructuring, which affected both the prior Supplier Quality Engineering group and Supply Chain Engineering roles. 3. Transforming the supplier management program from a reactive posture to a proactive, compliance-driven framework that supports the core business as a CDMO. 4. Enabling design & development and manufacturing teams to work with qualified suppliers who deliver quality parts and materials on time and to specification.

Requirements

BS in engineering or applied science and/or quality assurance plus 5+ years combined experience in quality and/or operational roles.
At least two (2) years in a medical device, aerospace or similarly regulated environment supporting design and/or manufacturing highly desired.
Working experience of Quality and Continuous Improvement tools
Experience with ISO 9001 and/or ISO 13485 requirements
Experience with RCA’s (Root Cause Analysis methodologies)
Ability to lead, review, and approve failure investigations and root cause corrective actions
Demonstrated ability to lead supplier quality audits
Develop interpersonal skills to foster trust and mutually beneficial relationships
Excellent written and verbal communication skills to convey detailed, complex information to technical and non-technical personnel
Ability to translate regulations and concepts into concrete programs and effectively promote to all levels of the organization

Nice To Haves

Certified Quality Auditor (e.g., ISO 13485, ISO 9001, AS9100)

Responsibilities

Closing significant supplier quality gaps identified as major risks during multiple audits (client audits, BSI audits, and internal audits).
Rebuilding supplier quality oversight capabilities lost through attrition and organizational restructuring, which affected both the prior Supplier Quality Engineering group and Supply Chain Engineering roles.
Transforming the supplier management program from a reactive posture to a proactive, compliance-driven framework that supports the core business as a CDMO.
Enabling design & development and manufacturing teams to work with qualified suppliers who deliver quality parts and materials on time and to specification.