Job Description

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  Day in the Life of a Quality &amp; Regulatory Manager
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 The mission of Unfors RaySafe AB is to help people avoid unnecessary radiation. We make solutions for personal dosimetry and quality assurance in diagnostic X-rays. Unfors RaySafe is part of Fluke Health Solutions, a division of Fluke Corporation.
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 To further strengthen our group, we are now looking for a Quality &amp; Regulatory Manager.
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 Quality &amp; Regulatory Manager will provide Quality Management, Regulatory and quality engineering expertise, direction, and hands-on involvement regarding quality processes, biomedical regulatory affairs, structures, and systems to drive continuous improvement in support of quality and compliance objectives. This position reports to the Global RAQA Director.
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  Responsibilities
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   Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes, and Client-side findings.
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   Supports the Director, RAQA for all Quality and Regulatory plans, actions, implementation, and upskilling as the Business grows.
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   Leads overall site compliance efforts. Regulations in scope: FDA applicable to class I and class II medical devices including 510k clearances. Prepare documentation for regulatory meetings with the FDA.
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   Completion of essential functions includes the effective application of Gage R&amp;R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.
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   Implements process and software validation policy and procedures and Validation Master Plan. Activities include: writing and executing protocols, data analysis, and report generation.
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   Ability to develop PFMEA and CP.
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   Fulfills quality systems subject matter expert role for all functional areas.
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   Maintains Process, Software and Product Risk Analysis to 14971:2012 requirements.
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   Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.
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   Prepares and conducts training sessions and presentations in support of quality objectives. Supports the Director, RAQA for Client Satisfaction processes and Business impact.
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   Actively participates in new product development teams and design change activities.
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   Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.
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   Maintains a professional working relationship with internal and external customers and support staff.
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   Actively manage and/or support and develop the Inspection Team, Regulatory Specialist, and others as needed
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  Your Team
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   We are rebuilding the RA/QA team from scratch, so the incoming RA/QA manager will have significant input in the personnel that joins his/her team
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   Historically, the RA/QA team is one that has been valued by the organization and peers and is relied upon to help drive continuous improvement
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   The RA/QA team is integrated well with the RaySafe organization and is included in all site celebrations and off-site activities; it is a very close-knit team and company!
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  Experience
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   Bachelor&rsquo;s degree (B.S.) in engineering from a four-year college or university.
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   Minimum of seven years experience in Regulatory and quality systems in an FDA-regulated industry.
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   Four years of people management experience. Track record of building and leading high-performance teams
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   Working knowledge of Quality Management Systems &ndash; 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
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   Formal training in quality engineering body of knowledge and tools, Certified RAPs, and/or Quality Engineer desired.
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  Personal Skills
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   Demonstrated ability to lead, grow in a Leadership position, and enable Team members to grow as well.
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   Marked ability to learn new applicable standards, determine how they apply to the Business and provide related guidance cross-functionally.
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   Strong interpersonal skills with the aptitude to be a team player and Leader; setting a professional tone and establishing a cooperative partnership within the department and other areas of the Company to effectively resolve problems.
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   Ability to interpret trends and data, translating the information into actions, outcomes, and improvements
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   Excellent documentation skills, with a solid process orientation and effective attention to detail
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   In-depth knowledge of regulatory quality principles and technical tools (technical writing, problem analysis, control charts and other quality methodologies) with the ability to train others.
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  Why you should join Fluke
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   Great colleagues who are passionate about their work
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   A possibility to learn about and follow interesting products from birth to re-birth
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   Make a change: we save lives by reducing radiation!
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   A global organization
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 As we interview candidates continuously, we look forward to receiving your application as soon as possible.
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  Fortive Corporation Overview
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 Fortive&rsquo;s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.
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 We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We&rsquo;re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.
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 We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.
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 At Fortive, we believe in you. We believe in your potential&mdash;your ability to learn, grow, and make a difference.
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 At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.
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 Fortive: For you, for us, for growth.
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 Fluke is leading the world in creating software, test tools and technology that will support customers today and in the future. We are a customer-obsessed market leader with a strong reputation for reliability, quality and safety.A wholly owned subsidiary of Fortive Corporation (www.fortive.com), Fluke is a global corporation headquartered in the greater Seattle area. Driven by the successful Fortive Business System, Fluke offers the passion of a startup with the resources of a Fortune 500 company. We are focused on the growth of our individual employees, teams and the Fluke brand. We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
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 This position is also eligible for bonus as part of the total compensation package.
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