Supplier Quality Engineer

About the role

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.

Responsibilities

• Establish, implement, and maintain robust supplier quality management processes within our CDMO operations.
• Close significant supplier quality gaps identified as major risks during multiple audits (client audits, BSI audits, and internal audits).
• Rebuild supplier quality oversight capabilities lost through attrition and organizational restructuring.
• Transform the supplier management program from a reactive posture to a proactive, compliance-driven framework.
• Enable design & development and manufacturing teams to work with qualified suppliers who deliver quality parts and materials on time and to specification.

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.

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.
• Working experience with 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.
• 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.

Qualifications

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

Pay

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.

Schedule

This is an on-site position in San Diego.