QA Supervisor (Product Quality)

Work Schedule

Environmental Conditions

Job Description

When youre part of the team at Thermo Fisher Scientific youll do important work. Surrounded by collaborative colleagues youll have the support and opportunities that only a global leader can give you. Our respected growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

When youre part of the team at Thermo Fisher Scientific youll do important work. Surrounded by collaborative colleagues youll have the support and opportunities that only a global leader can give you. Our respected growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

Location/Division Specific Information

7 Gul Circle

Discover Impactful Work:

• Lead a team of Quality Engineers and technicians to sustain Quality Assurance and QMS processes.
• Collaborate with the Site Quality Manager in establishing department objectives and crafting performance metrics ensuring they are consistently achieved.
• Support Site Quality leader in accomplishing quality objectives as assigned.

Quality Assurance and Change Management:

• Responsible for change management process which includes QMS and new product release and changes based on approved and released documentation as defined in respective processes SOP and project responsibilities.
• Ensure Quality Management Systems are compliant with regulatory and quality standards
• Engagement with engineering team in the development of new manufacturing procedures/materials/supplier to support the release of new products.
• Review and approve validation packagages changes to DOPs manufacturing process components software and labeling processes.

Audits and Compliance:

• Handle internal audits by plan and coordinate to ensure the internal audit findings are rectified and corrective action is implemented.
• Support external audits and follow up on external audit findings and corrective actions.
• Ensure quality systems and procedures are in compliance with ISO 13485 MDSAP FDA 21 CFR Part 820 IVDR

Quality Initiatives and Continuous Improvement:

• Lead the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
• Drive continuous improvement projects through Practical Process Improvement to ensure the timely and accurate completion of quality projects and tasks.

Quality Management and Data Analysis:

• Provide management with quality data and trends in product performance in meeting customer requirements.
• Review customer complaints and analyze data for trends.
• Identify quality issues through data and trend analysis work with relevant functions on corrective and preventive actions.
• Review non-conformance deviation and risk management for product and processes
• Drive customer complaint investigation through FA analysis and improve Out of Box Quality metrics (OOBQ) for instruments.
• Conduct investigation / trending relating to finish product performance failures. Identify and implement corrective and preventive actions as necessary.

Qualification

Degree in engineering or equivalent.

Experience

• Minimum 5 years of equivalent QA/QMS experience. Preferable in biotechnology life science or medical device industry.
• Experience with people management is a plus.
• Proficiency in handling instrument and consumable manufacturing is an advantage.
• Proficiency in computer systems for laboratory test analysis and data management. Experience in implementing LIMS system is an advantage.
• Working knowledge of cGMP QSR and ISO 13485 compliance is preferred.
• Experience with leading audits is an advantage

Competencies preferred

• Strong written and verbal communication skills and demonstrated ability to meet deadlines and work independently in a fast pace environment.
• Require strong organizational skills and attention to details.
• Must be self-motivated result oriented and work well with other collaborators with minimal supervision.
• Able to work in dynamic environment with ambiguous and changing priorities.
• Demonstrated expertise in cultivating engaged work teams and facilitating their professional development

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!