Job details
Job type full-time
Full job description
Job title: quality assurance senior manager
Requisition id: 177998br
When you’re part of the team at thermo fisher scientific, you’ll do meaningful work, that makes a positive impact on a global scaleJoin 80,000 colleagues who bring our mission to life each day to enable our customers to make the world healthier, cleaner and saferYou’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/division specific information
Remote / genetic sciences division
How will you make an impact?
The quality assurance senior manager is responsible for overseeing the ‘end to end’ design control and product development lifecycle management of ivd products to ensure that products meet applicable regulatory requirements and specifications for its intended use consistently.
What will you do?
Provide oversight, training, and direct review of quality documents and records related to implementation and/or compliance with ivd regulations for specific gsd (genetic science division) platforms.
Lead design transfer activities for complex npi projects in collaboration with cross-functional stakeholders including r&d, supply quality, supply chain/procurement, technical operations, manufacturing and quality operations.
Responsible for establishing design assurance requirements and deliverables with external partner (e.g., oem) for npi projects.
Utilize risk management tools use by the organization in accordance with documented procedures, including but not limited to dfmea, pfmea, fault tree analysis, etcOversee the plans to mitigate the both product and process risks identified through the risk management process.
Ensure that product validation and design activities are handled in a manner that complies with all applicable regulatory requirementsServes as the subject matter expert on validation processes.
In collaboration with cross-functional team members, shall also provide oversight for the satisfactory resolution of any quality or compliance issues related to released products that are currently on the market.
Ensure the product design history file (dhf) is auditable, traceable, concisely organized, complete, and supports regulatory product registration needsProvide technical expertise for post market investigations and design changes.
Represent areas of responsibility, in particular design control activities, during external audits such as fda inspections and notified body audits
Hire and retain a diverse, highly qualified staff and provide ongoing performance feedbackSet goals which align to department plans and manage the execution of goals through coaching and mentoringDirect the design quality assurance team, providing mentoring, technical guidance and career growth planningMaintain a safe and professional work environment.
How will you get there?
Education
Bachelor’s degree in life sciences or engineering or related medical/ivd/healthcare field or equivalent experience.
Experience
Minimum of 10 years of professional experience in quality and regulatory roles in the medical device/ivd field.
Previous experience working in regulated environments working with regulatory agencies such as fda and eu notified bodiesExperience with regulatory audits including presenting during pre-market and post-market reviews
Knowledge, skills, abilities
Strong knowledge of medical device design control and risk management processes and regulations, including software as a medical device– e.g., 21cfr part 820, is14971, iso13485, iec62304, eu mdr, ivdr, etc.
Demonstrated understanding of product development lifecycles, design change and change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing
Demonstrated comfort working in a dynamic, fast-paced environment where strong organizational, leadership, and communication skills were required to be successful.
Strong ability to analyze, introduce, and drive process development improvements
Experience working in a broader enterprise/cross division business unit model preferredAbility to work in a highly matrixed and geographically diverse business environmentStrong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Ability to travel as required
At thermo fisher scientific, each one of our 80,000 extraordinary minds has a unique story to tellJoin us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo fisher scientific is an eeo/affirmative action employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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