Exciting new opportunity for a quality professional with strong people management and leadership skills! We are looking for a new Senior Manager, Quality Assurance to join our Quality team based at our production site in Roskilde, Denmark.

This key leadership position is accountable for improving product and process quality, compliance and improvements in quality systems, managing customer expectations and creating efficiencies within the quality group to meet business expectations

• Sets the overall quality strategy for the Roskilde site that supports growth and compliance readiness

• Actively participates in quality improvement projects to move the organization from QC to QA

• Carries out leadership responsibilities in accordance with the organization’s policies and applicable laws.

• Responsibilities include interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding, discipline of employees; addressing complaints and resolving problems.

• Provides leadership and mentor the QC lab, factory quality and the QA teams (5-7 direct reports; 35 indirect)

• Lead, maintain and create efficiencies in the Quality Management System to fulfill international quality system requirements (e.g. CFR 820, ISO 13485, and IVDD).

• Assure management reviews of the Quality System are held and properly documented to reflect the status of the Quality System effectiveness and resulting corrective actions and improvement plans/actions. Works closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained.

• Creates cross functional collaboration and influences all business functions to apply appropriate quality tools including Lean, Six Sigma, TQM principles, business process improvement methods and statistical methods (e.g. design of experiments, statistical process control).

• Maintains alliance with local and corporate Quality and Regulatory Affairs to ensure participation in and understanding of associated initiatives.

• Effectively manages Corrective and Preventive Action System. Works with various departments to identify actions required to assure corrective and preventative actions are properly documented and follows up to initiate and monitor timely completion of actions.

• Oversees the Internal Audit program assuring compliance with regulatory standards. Coordinate and participate in any external or customer audits.

• Set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.

• Manages Key Quality Business Metrics and Department Metrics.

• Act as the site Quality Representative with third party agencies, regulatory agencies and any government agency

• Other duties may be assigned, as required

• Bachelor’s Degree in Engineering or Science

• 10+years Quality Manager experience in an IVDD, ISO 9001 and ISO 13485 certified medical-device manufacturing company.

• Hands-on experience in managing CAPA system and SPC programs

• Experience with FMEA and other risk management tools

• Experience with problem-solving techniques such as PPI, 8D, DMAIC, PPS

• Strong, proven leadership, communication, and personnel management skills that inspire and motivate a team. Must have had experience with formal goal and objectives setting

• Must have experience working with and managing multiple projects and teams simultaneously

• Experience with MDSAP – Medical Device Single Audit Program would be an advantage

• Experience with Lean or Six Sigma improvement systems would be an advantage

• Experience in high volume plastics/molding industry would be an advantage

• Moderate computer skills including data-based programs such as excel and access and intermediate level user of MS Office (Word, Excel, Access and PowerPoint)

• Strong written and verbal communication skills in English and Danish

At Thermo Fisher Scientific, each one of our 70,000 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.

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.