Supplier Quality Engineer

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.

About the role

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:

• 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.

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

Job Complexity

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.

Pay

This is an on-site position in San Diego with an annual salary range of $95,000 - $125,000, based on experience and qualifications.

Benefits

In addition to base salary, Ascential offers a comprehensive benefits package.