Quality Assurance Director - Sterility Assurance
Marlborough , Massachusetts
August 04, 2016
Job Number



GE Healthcare

Business Segment

Healthcare Quality

About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.


GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Posted Position Title

Quality Assurance Director - Sterility Assurance

Career Level




Function Segment

Quality Assurance

Location(s) Where Opening Is Available United States

U.S. State, China or Canada Provinces




Marlborough, Waukesha

Postal Code


Relocation Assistance


Role Summary/Purpose

Responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and optimized Cost of Quality for GEHC. This is a key technical leadership position, affecting sterile part quality for installed base and NPI parts. This role will have deep domain expertise related to sterile products and processes, be responsible for an assigned product family, and have knowledge of applicable industry standards/best practices related to sterilization.

Essential Responsibilities

1. Improve supplier quality performance for sterile suppliers via Quality Plan implementation.

2. Approve supplier selection through robust qualification processes including those related to terminal sterilization and aseptic processing.

3. Assure supplier compliance to GEHC QMS and regulatory requirements through supplier monitoring process

4. Develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers.

5. Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures and Factory defects.

6. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with CAPA process.

7. Identify then coach and develop team members in Supplier Quality and Sterility Assurance best practices.

8. May lead project teams for key suppliers.

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws, regulations and standards as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

4. Knowledge and understanding of GEHC Purchasing Controls Procedure and associated Work Instructions and operates within them to ensure that all purchased product and services conform to specified requirements

5. Ensure a compliant and qualified supply base by conducting supplier evaluations, qualifications and audits. This includes special process evaluation of sterile product suppliers and contract sterilizers and laboratories.


1. Bachelors Degree in Microbiology, Biology, Biomedical Engineering, Chemistry or other natural science discipline.

2. Minimum 10 years experience in medical device and/or pharmaceutical manufacturing of sterile products, sterility assurance, quality assurance or regulatory affairs

3. Demonstrated experience with communicating and teaching industry standards and best practices.

4. Proficiency with Microsoft Excel Spreadsheet development and analysis.

5. Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross functionally and globally).

6. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes.

7. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design control, design verification and validation activities; ethylene oxide, irradiation, steam/moist heat and aseptic processing; sterile packaging validation; biocompatibility; production and process controls; cleanroom management and control; Corrective and Preventive Action (CAPA), complaints and risk management; and product quality improvement using tools such as six sigma, DFR etc.

8. Demonstrated ability to lead, acknowledge, develop, communicate and implement a strategy to ensure compliance.

9. Demonstrated collaboration, negotiation and conflict resolution skills.

10. Excellent oral communication and report, business correspondence and procedure writing skills.

Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Desired Characteristics

1. Ph.D. in Microbiology, Biology, Biomedical Engineering, Chemistry or other natural science discipline.

2. Industrial Sterilization of medical products.

3. ASQ Certified Quality Engineer

4. Certified Green Belt (Certified Black Belt preferred)

5. Previous leadership experience
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