Manager, Quality Control Testing – Interventional Oncology
Siemens Healthineers · Austin, TX · 1 mo ago
Quality Assurance$126k–$173k/yrFull-time
About the role
Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.
Responsibilities
- Lead daily QC testing operations supporting medical device manufacturing.
- Manage and develop QC testing staff, including training, qualification, and performance management.
- Ensure compliance with Quality System Regulations (QSR), internal procedures, and Good Documentation Practices.
- Review and disposition QC test results, deviations, OOS/OOT events, and investigations.
- Apply Statistical Process Control (SPC) methods to monitor process performance, detect trends, and drive improvements.
- Support sterilization-related quality activities including review of records and acceptance criteria (Steam, EO, Gamma).
- Support biocompatibility-related testing activities, risk assessments, and documentation.
- Partner with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Supplier Quality.
- Act as QC SME during internal, customer, and regulatory audits.
- Drive continuous improvement initiatives to reduce variation, rework, and retesting.
Requirements
- Bachelor’s degree in a scientific or engineering discipline or equivalent experience.
- 8+ years of experience in Quality Control, laboratory operations, or medical device manufacturing.
- 3+ years of people leadership experience.
- Experience with medical device manufacturing and product release testing.
- Working knowledge of Quality System Regulations (QSR) and ISO 13485.
- Experience applying Statistical Process Control (SPC) techniques in a manufacturing environment.
- Strong problem-solving, communication, and cross-functional collaboration skills.
Qualifications
- Experience with sterilization methodologies: Steam, Ethylene Oxide (EO), and Gamma.
- Experience supporting biocompatibility testing and biological safety activities.
- Experience with microbiology, environmental monitoring, water testing, or cleanroom programs.
- Experience supporting New Product Introduction (NPI) or manufacturing changes.
Skills
- Leadership and management skills.
- Technical expertise in Quality Control and medical device manufacturing.
- Statistical Process Control (SPC) proficiency.
- Collaboration and communication skills.
- Problem-solving abilities.
Benefits
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k) retirement plan.
- Life insurance.
- Long-term and short-term disability insurance.
- Paid parking/public transportation.
- Paid time off.
- Paid sick and safe time.
Pay
The Base Pay Range For This Position Is $125,920 - $173,140 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Schedule
Varian Medical Systems, a Siemens Healthineers company is hiring a Quality Control (QC) Testing Manager. This role is leveled as a Manager role designed to be onsite in Austin, TX.