Senior Manager, TM Testing
QuidelOrtho
full-time
Posted on:
Location Type: Office
Location: Pompano Beach • Florida • United States
Visit company websiteExplore more
Salary
💰 $135,000 - $175,000 per year
Job Level
About the role
- Lead and oversee quality control (QC) release testing operations across multiple global locations supporting the Transfusion Medicine line of business
- Ensure that all release testing activities are executed in compliance with global regulatory requirements, quality system standards, and internal procedures, enabling the timely and compliant release of IVD products to market while also supporting business growth and product lifecycle activities
- Accountable for developing talent, strengthening scientific and compliance capabilities
- Perform other work-related duties as assigned
Requirements
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
- 10+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR
- Proven ability to lead and develop high-performing teams and build future technical and people leaders
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations
- Excellent collaboration, influence, and communication skills across functional and organizational boundaries
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement
- Experience leading in a matrixed, global organization and managing competing priorities effectively
- Commitment to scientific integrity, compliance excellence, and continuous improvement
Benefits
- medical, dental, vision, life, and disability insurance
- 401(k) plan
- employee assistance program
- Employee Stock Purchase Plan
- paid time off (including sick time) and paid Holidays
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality ControlRelease TestingQuality System RegulationsISO 13485FDA 21 CFR 820IVDRData AnalysisCompliance InitiativesProblem-SolvingTalent Development
Soft Skills
LeadershipCollaborationInfluenceCommunicationAnalytical SkillsDecision-MakingContinuous ImprovementTeam DevelopmentOrganizational SkillsAdaptability