Director, Quality

Work Schedule

Other

Environmental Conditions

Office

Job Description

The Director, Design Quality Assurance will:

• Be accountable for the effectiveness of the Design Controls activities across the network, driving the strategy and roadmap to improve processes and culture for both new product introductions and sustaining product changes, with the incorporation of risk management principles and standards for the product lifecycle.
• Provide guidance and closely collaborate with leaders from Program management, Product management, R&D, Operations and site quality organizations to ensure Design quality assurance activities are performed to meet our customers, colleagues and regulatory requirements.
• Responsible to provide both functional and technical quality support from product concept to launch, on highly complex designs that incorporate software, instrument, assay and reagent elements.
• Responsible for measurement of product analytics during product development. Data is leveraged to drive risk based decision making with new product development teams and site quality as required.
• Direct and lead of team of technical minded Quality staff; responsible for coaching and development of the team.
• Act as Quality representative for the Product Commercialization Process for Genetic Sciences Division, Clinical Sequencing Division and Biosciences Division.

Keys to Success:

Education

• BS/BA degree in Engineering or in a Science field such as Software Engineering, Mechanical/Electrical Engineering, Chemistry, Microbiology, Biology, or Biochemistry.
• 15+ years of either R&D, Quality Assurance/Engineering, and/or Technical Operations in product development, with products that are regulated (IVD/IVDR, Medical Devices), Research Use Only (RUO), Veterinary Health and/or non-regulated.

Experience

• Knowledge and understanding of quality management systems and standards, such as ISO 9001 or ISO 13485.
• Experience with regulatory requirements and guidelines, such as FDA regulations, Cybersecurity guidelines, and other relevant industry standards ISO 14971, IEC 62304, IVDR/MDR, ANSI/AAMI HE75:2009 and IEC 62380.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Experience in working effectively to ensure quality and compliance requirements are designed/built into the products.
• Experience in product development lifecycles (including software development lifecycle management), design change and change control, design verification and validation methodologies, and manufacturing / production process control methodologies.
• Significant experience in applying risk management principles to regulated and non-regulated products (software, instrument, reagents, assays, etc) throughout the product lifecycle.

Knowledge, Skills, Abilities

• Strong verbal and written communication skills and can effectively communicate at multiple levels in the organization.
• Ability to work effectively within a team in a fast-paced changing environment.
• Results oriented with track record of developing, motivating, and leading strong/effective teams across multiple businesses/divisions.
• Ability to travel.

Compensation and Benefits

The salary range estimated for this position based in California is $160,100.00–$240,125.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards