Position Title: Analyst, Quality Systems Work Location: Santa Ana, CA 92705 Assignment Duration: 9 Months Work Arrangement: Onsite/Hybrid - The hiring manager expects approximately 3 days onsite and 2 days remote to allow the contractor to remain connected with the broader team.
Position Summary:
The Analyst, Quality Systems will support Supplier Quality documentation remediation activities, with a primary focus on completing Quality Agreement amendments with external suppliers.
This role will manage supplier outreach, negotiation, documentation, and follow-up to support timely completion of approximately 250 Quality Agreement amendments.
Background & Context:
The amendments are focused, one-page documents addressing specific Quality Agreement clauses rather than the negotiation of entirely new agreements.
A key area of focus is record-retention requirements driven by medical-device regulations.
Key Responsibilities:
Manage a portfolio of Supplier Quality Agreement remediation activities and amendments.
Conduct outreach to external suppliers and coordinate completion of Quality Agreement amendments.
Negotiate focused Quality Agreement language, including record-retention requirements, while maintaining effective supplier relationships.
Apply knowledge of purchasing controls and medical-device regulatory requirements when communicating expectations to suppliers.
Understand when to negotiate, when to compromise, and when issues require escalation to internal leadership.
Partner with Supplier Quality, Sourcing, Legal, and other business stakeholders to resolve supplier questions and drive agreement completion.
Maintain accurate documentation, communication records, status reporting, and project metrics.
Support document-control and record-control requirements related to Quality Agreement remediation.
Identify risks or delays and escalate issues appropriately to support timely project completion.
Qualification & Experience:
Experience working in the medical-device industry is required due to the regulatory requirements associated with the Quality Agreement remediation work.
Working knowledge of Quality Systems and medical-device regulations, including ISO 13485, EU MDR, and 21 CFR Part 820.
Understanding of Supplier Quality and/or purchasing controls.
Strong supplier-facing communication, negotiation, and relationship-management skills.
Ability to interpret regulatory requirements and translate them into supplier expectations.
Strong project-management, organization, follow-up, and documentation skills.
Strong problem-solving and critical-thinking skills.
Proficiency with Microsoft Office tools.
Bachelor's degree or equivalent experience in a related field.
2-4 years of relevant experience preferred.
Candidates without a bachelor's degree may be considered when they have substantial relevant experience.
Preferred Qualifications
Previous Supplier Quality experience.
Previous experience working with Quality Agreements or Quality Agreement amendments.
Familiarity with contract language or other supplier-facing contractual negotiations.
Experience with document control and record control.
Supplier Quality experience is preferred but not mandatory if the candidate has stronger medical-device regulatory knowledge and relevant negotiation experience.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $42.00/hr - $46.50/hr.
