Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them.

Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Location/Division Specific Information

The Middletown, VA site is a growing business within the Clinical Diagnostics Division, serving as the #1 dedicated supplier to the IVD Industry for custom, contract & OEM manufacture of hematology, hemostasis, clinical chemistry, immunoassay, and molecular diagnostics, supporting >10B tests per year globally.

Location/Division Specific Information:

This role is based at out Middletown, VA site supporting the Specialty Diagnostics Group.

How you will make an impact:

In this role you will work with the Director of Quality for the Middletown site and will have primary responsibility for leading the Quality Engineering functions. The Sr Manager, Quality Engineer will provide direction of the quality engineering team to support internal and external projects such as equipment changes and product transfers, provide daily support to manufacturing operations, including continuous improvement, process monitoring, risk assessment and CAPA and investigations.

What you will do:

• Optimally manage the Quality Engineering team to provide support to the manufacturing lines and departments to facilitate the production of high quality, compliant products that meet customer needs.
• Establish strategic and tactical role of the QE team, and roles and responsibilities.
• Establish and monitor relevant metrics to track and improve team performance, effectiveness and customer satisfaction. Drive continuous improvement in partnership across Quality Assurance and Operations.
• Develop and implement Quality Assurance policies and procedures supporting 21 CFR 820/ISO13485/MD-SAP/CE compliance.
• Support development projects, transfer projects, process changes and engineering projects to provide overall quality assurance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).
• Review and approval of IQ, QQ and PQS
• Provide direct feedback on any issue identified and work with subject matter experts for resolution.
• Support all departments regarding quality requirements and standards/regulation.
• Assist in training and maintaining compliance to regulations and procedures.
• Provide Quality Engineering support in resolving supplier-related quality issues and complaint investigations.

Minimum Requirements/Qualifications:

• Bachelor’s degree in Science or Engineering or related field with 10 years of experience, including at least 5 years in a leadership role.
• American Society for Quality (ASQ) certified engineer and preferred ASQ certified auditor.
• Six Sigma/Lean certified preferred.
• Minimum of 5 years quality experience with an FDA regulated manufacturing company.
• Detail oriented and can lead multiple projects and activities assigned.
• Excellent interpersonal skills, planning, communication and follow-up skills.
• Proficient in Microsoft Word and Excel. SAP and Master Control experience preferred.