Senior Quality Manager
Baxter Medical AB / Chefsjobb / Luleå
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hela Sverige Visa alla jobb hos Baxter Medical AB i Luleå,
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Lund eller i
hela Sverige Now we are looking for a Senior Quality Manager in Luleå, Sweden.
This is a great opportunity for you with a couple of years within QA wishing to grow into new responsibilities.
This is where you as a Senior Quality Manager is the quality leader for Manufacturing Operations, the plant, and support facilities can be part of our important mission to save and sustain lives. This role provides leadership to all functions within the Luleå, Sweden Operation to enable the organization to achieve Quality goals as well as aggressive growth objectives.
Essential Duties and Responsibilities
You will work as Quality Management Representative and PRRC (Person Responsible for Regulatory Compliance) for the manufacturing facilities, including hosting third party inspections and audits, and organizing and conducting periodic Management Reviews of the Quality System.
You will provide strategic direction and leadership to all functions and levels of the manufacturing organization to ensure operations adhere to the highest standards of compliance and product quality.
You will direct the implementation of corrective and preventive actions, ensuring timely and robust completion of actions to enterprise targets.
You will ensure product containment of manufacturing non-conformances, to include immediate correction activities as appropriate and determination of systemic corrective and preventive actions.
You will review complaint trending and drive actions to improve customer experience and lower complaints.
You will chair the local Corrective Action Board (CAB) and participate in the Corporate CAB.
You will be responsible for ensuring that the site participate effectively in monthly Product Performance Review meetings.
You will be responsible for product quality, including the transfer of product design to manufacturing facilities within the site.
You will oversee all aspects of supplier quality for the plants, including supplier selection, qualification, and control.
You will identify and mitigate gaps between Quality System requirements and all applicable regulations and corporate requirements.
You will be responsible for the quality of responses to FDA 483 observations, MOH observations, WL and other regulatory compliance correspondence from site and for ensuring completion of all GMP commitments to regulatory authorities (FDA, MOH's, Notified Body, etc..) at sites.
You will lead, coach and train employees toward team concepts and foster an environment for empowered, high performance environment.
Qualifications
• Bachelor's degree in a related medical, science or regulatory discipline required, engineering degree nice to have
• Knowledge and understanding of medical device regulations and standards, including but not limited to QSR, CMDR, Medical Device Directive
• ISO Quality System and other applicable industry requirements is required.
• 10+ years in the medical device industry or related GMP environment or equivalent.
• 5+ years of experience leading direct reports.
• Excellent verbal and written communication skills, including attention to detail; strong questioning and listening skills; and the ability to look beyond obvious answers in order to understand the impact on other areas is required.
• Exceptionally strong leadership and influencing skills.
• Must have the ability to make effective presentations to all levels of the organization.
• The proven ability to prioritize and manage multiple projects and meet deadlines is required.
• Must have the ability to work in both a collaborative (team) environment as well as perform independent work as required.
• Experience building a high performing team, managing performance of team members with varying levels of skill and experience, and mentoring high potential individuals to achieve greater impact on the organization.
• Strong appreciation of the impact of regulatory bodies on medical device product lifecycle is required.
• ASQ Certifications for Auditing and/or Quality Management is preferred
What we can offer
• A developing opportunity for you and a chance to work in a diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
• Independent position with an opportunity to build your own strategy and make a real impact.
• A chance to further build your professional experience in the area of health care.
• Internal training tailored to business needs and career goals.
• Stability of employment in a recognizable and established company.
• You will gain excellent exposure and fantastic industry knowledge within the territory working for a global organization.
If you like the sound of the above role and if this role resonates with you, then we'd love to talk to you. Apply here as we would love to discuss it in more detail with you.
Så ansöker du Sista dag att ansöka är 2023-02-09
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Baxter Medical AB (org.nr 556171-0657)
Nedre vägen 100 (
visa karta)
972 52 LULEÅ
Arbetsplats Liko Ab/baxter Medical AB
Jobbnummer 7326111
Observera att sista ansökningsdag har passerat.