Senior CAPA Specialist (Pharmaceutical Quality)

Location: Onsite five days per week at the Rice Creek facility in Fridley, Minnesota, with support for the Plymouth Cheshire facility and travel between sites.

Salary: $93,600–$140,400 USD annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies focused on alleviating pain, restoring health, and extending life for patients worldwide.

What you will do

• Lead CAPA activities from initiation through effectiveness verification and closure.
• Review investigations, root cause analyses, corrective action plans, and quality system records.
• Partner with manufacturing, quality, operations, and compliance teams to drive sustainable process improvements.
• Monitor CAPA metrics, trends, and reports to identify compliance risks and improvement opportunities.
• Support internal audits, regulatory inspections, audit readiness, and closure of observations.
• Mentor team members and support quality system performance and compliance projects.

Requirements

• Bachelor’s degree with 4+ years of relevant experience, or a master’s degree with 2+ years of relevant experience, in Quality, Manufacturing, Engineering, Life Sciences, or a related regulated environment.
• Experience managing CAPA processes within a regulated industry.
• Experience with root cause investigations, corrective action plans, and quality system requirements.
• Experience working cross-functionally on issue resolution and process improvement.
• Experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments is preferred.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not available for roles below the Principal level.

Nice to have

• Experience supporting regulatory inspections and internal or external audits.
• Knowledge of Quality Management Systems such as TrackWise.
• Experience analyzing quality system data and developing compliance or performance metrics.
• Project leadership experience in quality or continuous improvement initiatives.

Culture & Benefits

• Onsite collaboration across manufacturing, quality, operations, and compliance teams.
• Health, dental, and vision insurance, plus health and flexible spending accounts.
• Paid time off, paid holidays, short-term and long-term disability coverage, and life insurance.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance, dependent daycare spending account, and employee assistance resources.