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.
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.
