Senior Supplier Quality & Compliance Analyst (Medical Devices)

Location: Alameda, California, United States; hybrid workplace with willingness and ability to work on site required

Annual base salary: $113,000–$150,000 per year

Company

hirify.global is a global healthcare company that designs, develops, manufactures, and markets medical products and therapies for challenging medical conditions.

What you will do

• Organize and lead the external supplier audit program, including audit planning, logistics, documentation, closing meetings, and follow-up.
• Assess supplier compliance with applicable quality, regulatory, and internal requirements and prepare audit reports and recommendations.
• Evaluate supplier corrective-action responses and determine when additional evidence, remediation, or escalation is needed.
• Prepare, review, and update Supplier Quality Agreements and maintain the Approved Distributor List and supplier quality records.
• Manage NCRs, CAPAs, ECOs, supplier issues, and improvements to quality procedures, work instructions, and controls.
• Collaborate with Supplier Quality Engineering, Procurement, internal departments, customers, suppliers, and distributors; mentor junior analysts.

Requirements

• Bachelor’s degree in science or a related field, plus 7+ years of quality systems experience, preferably in a medical device environment, or equivalent experience.
• Working knowledge of QSR, ISO, applicable regulations, laws, and current Good Manufacturing Practices.
• Experience with statistical methodologies and analysis.
• Training and experience in internal and external audits, with the ability to lead supplier audits and manage complex priorities.
• Strong written, oral, and interpersonal communication skills and proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability and willingness to work on site in Alameda and move between buildings and floors; business travel may range from 0% to 25%.

Nice to have

• ASQ CQA certification.

Culture & Benefits

• Collaborative environment with continuous learning and performance recognition.
• Medical, dental, vision, life, AD&D, short-term and long-term disability insurance.
• 401(k) with employer match, paid parental leave, paid sick time, and at least fifteen vacation days per year.
• Eleven paid company holidays per year and an equity program where applicable.
• Work may take place in office, production, warehouse, laboratory, and controlled environments.