Site Quality Head

at  Thermo Fisher Scientific

Austin, TX 78744, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate29 Dec, 2024Not Specified30 Sep, 202410 year(s) or aboveLife Sciences,Iso,Leadership Skills,Compliance Regulations,Personal DevelopmentNoNo
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Description:

JOB DESCRIPTION

What sets this opportunity apart is the opportunity to lead and influence the future of quality management at the Austin Site for a globally recognized organization. Our passionate team is dedicated to driving improvements and ensuring seamless operations. As the Sr Manager, Quality, you will play a crucial role in our commitment to enhancing customer satisfaction and establishing benchmarks in the industry.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

  • Bachelor of Science Degree in Life Sciences, Engineering, or related science/engineering degree preferred.
  • 10+ years of professional quality experience, with quality leadership experience preferred.
  • Understanding of Life Sciences and IVD/Medical Devices industries and required compliance regulations for Genetic Sciences products and processes.
  • Solid understanding and experience with ISO 9001 and ISO 13485 standards.
  • Experience in MDSAP, IVD/IVDR, 510K, and GxP requirements preferred.
  • Ability to travel domestically and internationally up to 15%.
  • Proven knowledge and experience implementing Design and Process FMEA’s, CAPA process, NPI process, Complaints Handling process, and Change Control process.

DESIRED QUALIFICATIONS:

  • Demonstrated leadership as a valued team member and colleague with leaders at all levels.
  • Experience working and providing customer support, investigations, and relationship management.
  • Confirmed communication and customer leadership skills.
  • Experience supporting organizational change efforts.
  • Demonstrated people leadership skills.
  • Personal awareness and desire for continual learning and personal development.
  • Hands-on and productive, with minimal instruction required for day-to-day work.
  • Strong interpersonal, verbal, and written communications skills are crucial.

Responsibilities:

  • Support and provide expertise to the Quality Management System (QMS) to successfully implement and exceed goals and targets.
  • Collaborate with various functions to ensure the quality management system is comprehensive, incorporates standard processes, and aligns with the strategic plan.
  • Oversee product development responsibilities, including design controls, risk management, document control and record management, and supplier management.
  • Manage manufacturing responsibilities, including master records, training, process controls, labeling, change control, and CAPA.
  • Monitor and measure validations, calibrations, customer feedback and complaints, and internal audits.
  • Report all site quality metrics for monthly and quarterly business reviews, such as Product Complaint rates, Cost of Poor Quality, and CAPA.
  • Provide quality expertise to business process transfer activities, such as process implementation/validation.
  • Hire and retain a diverse, highly qualified staff, providing ongoing performance feedback. Set and lead goals aligned with department plans through coaching and mentoring.
  • Ensure continuous improvement through Practical Process Improvement (PPI) and maintain a quality culture that emphasizes “Right First Time.”


REQUIREMENT SUMMARY

Min:10.0Max:15.0 year(s)

Information Technology/IT

Production / Maintenance / Quality

Other

BSc

Life sciences engineering or related science/engineering degree preferred

Proficient

1

Austin, TX 78744, USA