Quality Assurance Professional - Medical Devices & GMP Compliance
Overview
Own quality systems across manufacturing operations in a medical device setting with a hybrid location in Phoenix. Partner with cross functional teams to run NCR, CAPA, Change Management, and post implementation validation. Ensure audit readiness and continuous improvements through robust corrective actions and effective training. This role stands out through hands on quality system execution, software validation, and a strong emphasis on timely decision making.
What You'll Do10
- 1Build and coordinate NCR and CAPA processes across product lines to enable timely issue closure
- 2Lead Change Management and FIR activities improving post implementation effectiveness
- 3Support audit readiness and coordinate internal and external audits achieving compliant results
- 4Guide manufacturing teams through daily quality system requirements enabling rapid, risk based decisions
- 5Train colleagues on quality system practices and Good Documentation Principles to maintain compliance
- 6Enhance quality systems including software validation and ERP/PLM related improvements
- 7Participate in and execute quality system compliance audits and product failure investigations
- 8Work with cross functional teams to address product issues and execute corrective actions
- 9Monitor and improve quality metrics to sustain regulatory compliance and operational excellence
- 10Coordinate product investigation processes ensuring timely documentation and approvals
Requirements5
- 1Minimum of 4 years of Quality Assurance experience in regulated industries such as medical devices or pharma
- 2Demonstrated knowledge of FDA medical device quality system regulations and ISO standards
- 3Excellent written and oral communication skills and strong interpersonal abilities
- 4Ability to work independently and as part of a diverse team with aggressive timelines
- 5Willingness to travel up to 5% and support hybrid work arrangements
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Premier Global Links
VerifiedQuality Manager, Medical Devices & ISO 13485 Quality Assurance
Own manufacturing quality operations at scale, leading quality engineers and QC functions to ensure compliant production and continuous improvement. Lead NCR/MRB, CAPA, and supplier quality while partnering with Manufacturing, Engineering, Supply Chain, and Operations. Drive data driven decisions and risk reduction with Lean and Six Sigma methodologies. This role offers hands-on leadership in a regulated environment and opportunities to shape quality culture.
Actalent
VerifiedQuality Manager Medical Devices
You own quality and regulatory compliance for a growing medical technology startup, ensuring products meet FDA 21 CFR Part 820 and international standards. You will lead the QMS, manage supplier quality, and drive continuous improvement across the product lifecycle. Collaborating with a team of eight in St. Paul, you'll shape processes from design to post-market surveillance. This role offers direct impact in a startup environment and the chance to build quality systems from the ground up.
Abbott Laboratories
VerifiedPrincipal Quality Engineer, Medical Devices CAPA
As a Principal Quality Engineer at Abbott Laboratories, you will own complaint investigations and CAPA programs for medical devices impacting millions of patients. You will bridge R&D, Operations, and Quality teams to drive root cause analysis and product improvements. This role requires deep technical expertise in FDA and ISO regulated environments, with a focus on data-driven decisions and process optimization. You will set global standards for specifications, ensuring critical quality attributes are highlighted. A unique opportunity to lead large-scale investigations and shape quality systems at a Fortune 100 healthcare leader.
Apex Systems
VerifiedPost Market Quality Technician, Medical Device
You own post-market quality assurance for medical devices in a contract role at Apex Systems, supporting a client in Acton, MA. You review complaints, analyze trends, and drive corrective actions to keep products safe and compliant. You join a team of quality engineers and work directly with manufacturing and regulatory affairs. This 3-month project offers a chance to apply ISO 13485 and FDA QSR standards in a hands-on role.
Hims-And-Hers
VerifiedQuality Assurance Specialist, Pharma & Healthcare Analytics
Own data driven quality performance systems within pharmaceutical and regulated healthcare operations at scale. Build insights from multiple data sources to drive CAPAs, deviations, and supplier quality improvements. Partner with QA leadership and Operations to align with cGMP and USP standards and support inspection readiness. This role bridges data and action to improve safety, compliance, and efficiency.
Actalent
VerifiedQuality Systems and Compliance Manager
Lead a team of five Quality Assurance professionals to drive quality and compliance initiatives across the organization. Own QMS processes ensure regulatory compliance and audit readiness. Foster continuous improvement and manage audit findings. Close quality events while maintaining compliance. Drive performance management and employee development. Partner with HR on staffing and leadership development. Differentiate by scaling quality systems and leveraging expertise.