Senior QA Manager, Sensory

Role: Full-time permanent

Location: Taastrup, Copenhagen, Denmark

About Natus: We’re the leading manufacturer of medical devices and software for a range of specialities, including newborn care, neurology, sleep, hearing, and balance markets. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. Our Irish base in Gort, Co. Galway, manufactures and distributes a range of medical device products used in the diagnosis of human neurological disorders. “The success of our company depends on our employees. This is where you come in”.  If you are a strong leader with a proven track record in motivating and leading a team. A natural problem solver with strong organisational skills. Driven, and want to make an impact...this role may be for you…

Job Overview:

The Senior QA Manager will direct and oversee the Quality Assurance, Quality Engineering and Quality Systems areas while building and maintaining successful relationships with functional stakeholders. You will report to our Senior Director RA based in Gort, Ireland.

Leadership tasks:

•This position is expected to champion the Sensory division’s separation from the Natus corporation. The separation activity will occur in all Sensory sites globally including the USA, Canada, Ireland, Denmark, Australia, and China. This role requires excellent leadership skills to effectively engage with local and global leaders to deliver on local and global solutions.

•In this role, the Senior QA Manager will lead, develop and guide a dynamic medical device QA team through the separation process. They will be expected to bring guidance on best practice QMS systems and processes, implement and build on these best practices making them specific to the Sensory business, all the while building a standalone Sensory quality management system.

Quality:

•This role will lead engagement and interaction with key internal customers, including the product design, operations, engineering, and continuous improvement teams.

•Provide quality system compliance with major Regulatory Authorities (U.S. FDA, Health Canada, Australian TGA, Brazilian ANVISA, Japan MHLW and PMDA, and the European Union).

•Promote education and awareness of the global regulation applicable to the Sensory division.

•This role will lead the separation activity by recommending the scope, terms and systems needed to establish a standalone Sensory QMS.

•Lead and develop the quality personnel through the separation.

•This role will also be the designated management rep and the point of contact for all internal and external audits Responsible for processes within Document Control, CAPA, Internal Auditing and Complaint Handling, NCR, Change management, Supplier management, incoming inspection, employee training.

•Responsible for providing inputs to Quality Metrics and Management Review.

•Support Quality System related project activity as required.

•Drive robust and effective corrective and preventive action programs through the CAPA system, ensuring the use of appropriate problem-solving tools.

•Ensure Quality System processes are lean, compliant, user-friendly and are well understood through-out the organization.

Development of the QA Team:

•Regular training/briefing sessions to the QA team on aspects of the quality management system separation and resulting changes.

•Provide periodic training for company personnel on the company’s Quality Systems processes and procedures.

•Encourage and develop the QA Team to take an active role in driving improvement initiatives in the Quality Management system.

•Ensure the QA team drive and enhance a compliance culture so the Sensory business can thrive.

Your profile:

•Minimum of 10 years working in a quality role(s) in the medical device or similar industry.

•Ideally have minimum 5 years of experience in a management role in a matrix organization.

•Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for medical device manufacture.

•Possess a strong quality & compliance background and the ability to communicate effectively in a cross-functional team environment.

•Preferably bachelor’s degree in a technical discipline to include: Science, Quality or Engineering.

•Excellent communication and interpersonal skills.

Compensation and Benefits:

• Competitive salaries.
• Pension scheme.
• Flexible Work Schedule (3 days/week onsite or fully onsite if you prefer).
• Convenient location in Taastrup, Denmark with a private parking lot, as well as close proximity to a bus stop and biking distance to the train station.
• Catered lunch in the company canteen.
• Breakfast on Thursdays.
• Friendly and talented colleagues.
• Online Learning.
• Chance to work with world-class products.

EEO Statement:  Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

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