Quality Control and Regulatory Assurance Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

The Opportunity
At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
When you’re a part of our team, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team, and help us make significant contributions to the world!
How will you make an impact?
The Quality and Regulatory Manager will be part of a cohesive team responsible for leading the overall quality program for the site and product lines including production/process quality, supplier quality, customer driven project specific quality requirements and product regulatory requirements. In a direct aspect this role will be responsible for Deviations, CAPAs, Internal and External Audits, Customer Complaint and Change Control for all phases of manufacturing. The individual selected for will act as an effective leader in promoting quality directives, decisions and practices and will apply sound, systematic, problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues. Provide quality guidance, support, and leadership in the design, development, and design transfer processes for new product/service development projects; collaborating with other project team members to evaluate established requirements and identify measures critical for site adoption of programs. They will support the drafting, assembly, and filing of submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality, and are presented in a manner to facilitate review, and are in conformance with appropriate regulations and guidelines.

Key responsibilities will include, but not limited to:

• Build a culture committed to quality, ensuring accordance with applicable regulatory requirements, internal quality standards, and customer needs.
• Lead the implementation of quality assurance practices, process controls, and Corrective and Preventive Action activities.
• Performing and maintaining product/process risk analysis (FMEA, DFMEA, PFMEA), and supporting the investigation of nonconformance, audit findings, CAPA’s, complaints, and SCAR’s by conducting CAPA investigations, root cause analysis and effectivity checks.
• Reviewing and managing customer quality and regulatory requirements.
• Reviewing supplier manufacturing processes and collaborating with them on process improvement opportunities.
• Approving investigations, deviations, change controls, validation protocols, validation reports, Operations SOP’s, and in-process controls.
• Supporting vigilance activities, including implementing and monitoring recalls and field actions.
• Recommending process changes to improve the Value Stream performance and regulatory compliance.
• Contributing to the ongoing development and continuous improvement of requirement management, risk management, design and development, design transfer, change management, defect management, supplier quality, and quality management system (QMS) related procedures and processes.
• Remaining current on developments in field(s) of expertise, regulatory requirements, and industry trends.
• Independently reviewing and monitoring changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
• Handling product regulatory certifications, including filings and records.
• Connecting with global regulatory and quality teams for business changes and projects relating to role and working with site team to implement standard processes from the global organisation.
• Acting site lead as required with reporting and liaison with Senior Leadership
• Other related tasks as assigned by Management.

What you will bring to the team:

• Bachelor’s degree in Science or Engineering or related field or 7+ years of related experience in lieu of degree.
• 4+ years quality engineering experience within a manufacturing environment.
• Experience leading a team with broad skills and functional requirements.
• Solid understanding of global regulatory and quality requirements associated with electromechanical devices such as CE, GOST, ROHS would be beneficial.
• Lead Auditor certification would be ideal.
• Proven interpersonal skills and communication skills across all levels of an organisation.
• Consistent track record in balancing multiple priorities and meeting objectives in a results-orientated and fast-paced environment.
• Adaptable to working independently and in multidisciplinary teams, and proficient in leading projects.
• A personal dedication to high standard of work and attention to detail.
• Shows consistent initiative and determination.
• Experience in formal problem solving in a team environment.
• Ability to work independently and to collaborate effectively in interdisciplinary teams.
• Excellent organizational skills, planning, communication and follow-up skills.
• Proficient in Microsoft Word, PowerPoint, and Excel.

What’s in it for you?
We offer a competitive salary and performance related bonus structure, recognition and awards program for individual and team performance or for taking an active approach to help our colleagues, culture and customers. Opportunities as a team member of a rapidly growing global organisation including access to training and development through Thermo Fisher’s Global University centre. Joining an extraordinary team of professionals working together to make a difference for our customers and for our world!

Special Conditions:

• Some out of hour’s work may be required

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status

• Build a culture committed to quality, ensuring accordance with applicable regulatory requirements, internal quality standards, and customer needs.
• Lead the implementation of quality assurance practices, process controls, and Corrective and Preventive Action activities.
• Performing and maintaining product/process risk analysis (FMEA, DFMEA, PFMEA), and supporting the investigation of nonconformance, audit findings, CAPA’s, complaints, and SCAR’s by conducting CAPA investigations, root cause analysis and effectivity checks.
• Reviewing and managing customer quality and regulatory requirements.
• Reviewing supplier manufacturing processes and collaborating with them on process improvement opportunities.
• Approving investigations, deviations, change controls, validation protocols, validation reports, Operations SOP’s, and in-process controls.
• Supporting vigilance activities, including implementing and monitoring recalls and field actions.
• Recommending process changes to improve the Value Stream performance and regulatory compliance.
• Contributing to the ongoing development and continuous improvement of requirement management, risk management, design and development, design transfer, change management, defect management, supplier quality, and quality management system (QMS) related procedures and processes.
• Remaining current on developments in field(s) of expertise, regulatory requirements, and industry trends.
• Independently reviewing and monitoring changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
• Handling product regulatory certifications, including filings and records.
• Connecting with global regulatory and quality teams for business changes and projects relating to role and working with site team to implement standard processes from the global organisation.
• Acting site lead as required with reporting and liaison with Senior Leadership
• Other related tasks as assigned by Management