Quality Assurance Manager

ITH Icoserve; Llanberis; On-site; GBP 40,000 - 80,000; Full time

Job summary

Join a pioneering healthcare company as a Quality Assurance Manager, where you'll lead a dedicated team in ensuring compliance and quality across processes. This role involves managing quality-related matters, conducting risk assessments, and implementing process improvements in a dynamic environment. With a strong focus on FDA regulations and a commitment to excellence, you'll play a crucial role in enhancing product quality and operational efficiency. This innovative firm values diversity and offers a supportive community for professional growth, making it an exciting opportunity for those passionate about quality management in healthcare.

Benefits

26 days' holiday

Up to 10% employer pension contribution

Share and bonus scheme

Private medical insurance

Dental cover

2 paid volunteering days per year

24/7 employee assistance programme

Qualifications

• Mindestens 5 Jahre Erfahrung im Qualitätsmanagement in einem regulierten Umfeld.
• Kenntnisse in FDA-Vorschriften und Risikomanagement sind erforderlich.

Responsibilities

• Leitung eines Teams für Eingangsprüfungen und Lieferantenqualität.
• Verantwortung für Prozessqualität und Aktualisierung der Qualitätssystemverfahren.

Skills

Qualitätsmanagement

Risikomanagement

FDA-Vorschriften

Prozessverbesserung

Education

Diplom oder Abschluss in Qualitätsmanagement

Mechatronik

Elektrotechnik

Maschinenbau

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Apply now for the position of Quality Assurance Manager and you will act as a key member of the site Quality Management team with combined responsibility for all general Quality Assurance activities at the site and at corporate level.

Your Role:

• Designated as the primary point of focus for all Quality Related matters associated with Instrumentation Quality.
• Leading a team responsible for Incoming Material Inspection and Supplier Quality for all aspects of the business.
• Contributing and leading in a broad range of activities including process change, risk assessment, CAPA, non-conforming material, complaint handling, manufacturing process deviations, non-conformance handling and validation.
• Active in change management via verification and validation of product, process change, technology transfer plans, equipment commissioning, deviations, non-conforming material, out of tolerances, complaints, continuous improvement changes, and post-production (proactive surveillance). This will require a systems mindset incorporating a cross technology understanding, in addition to a core appreciation of risk and regulatory requirements.
• Act as a key liaison and knowledge transfer champion among Quality Assurance, Manufacturing Engineering, R&D, Production and Documentation Control.
• Focus on and be responsible for process quality design improvements and updating quality system procedures to achieve both fully compliant and lean processes.

Your Expertise:

• 5 years minimum Quality Management experience in a similar role.
• 5 years minimum of relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management incl. writing and/or reviewing Quality related procedures, plans, and reports.
• Minimum of a third level qualification (Diploma/Degree) in an appropriate discipline (Quality Management, Mechatronics, Electronics or Mechanical Engineering) OR appropriate and commensurate experience.

Our Benefits:

• 26 days' holiday with the option to buy or sell an additional 5.
• Up to 10% employer pension contribution.
• Share and bonus scheme.
• Access to our flexible benefits from private medical insurance to dental cover.
• Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme.

Who we are:

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.