Supplier Quality Engineer

Ascential Technologies; San Diego (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

Ascential Medical and Life Sciences seeks a Supplier Quality Engineer to strengthen our supplier quality program in a regulated medical device environment. You will close gaps identified in client, BSI, and internal audits and rebuild oversight capabilities after attrition and restructuring.

You will lead supplier quality audits, drive root-cause investigations, and transform our supplier management framework to be proactive and compliant, supporting design, development, and manufacturing teams

Qualifications

• Experience in quality and/or operational roles (5+ years).
• Experience in medical device, aerospace or similar regulated environments (2+ years).
• Familiarity with quality systems and continuous improvement tools.

Responsibilities

• Close significant supplier quality gaps identified as major risks in audits.
• Rebuild supplier quality oversight capabilities after attrition/ restructuring.
• Transform supplier management from reactive to proactive, compliance-driven for a CDMO.
• Enable design, development and manufacturing teams to work with qualified suppliers delivering quality parts on time.

Skills

Quality tools

ISO 9001/13485

Root cause analysis

Audits

Communication

Supplier quality management

Interpersonal skills

Regulatory translation

Certified Quality Auditor

Education

BS in engineering or applied science

Job description

Description

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.

Job Details

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

• 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.

Education, Experience, Skills And Abilities Required

Education and Experience

Experience typically acquired through a 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.

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.

Knowledge, Skills & Abilities

• 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)

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

Compensation is based on several factors including experience, skills, education, and job-related knowledge. In addition to base salary, Ascential offers a comprehensive benefits package.

Equal Opportunity Employer

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