Analyst, Quality Systems

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.

 

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.