Quality & Regulatory Manager
Fortive
- Sverige
- Permanent
- Heltid
- 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.
- Supports the Director, RAQA for all Quality and Regulatory plans, actions, implementation, and upskilling as the Business grows.
- 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.
- Completion of essential functions includes the effective application of Gage R&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.
- Implements process and software validation policy and procedures and Validation Master Plan. Activities include: writing and executing protocols, data analysis, and report generation.
- Ability to develop PFMEA and CP.
- Fulfills quality systems subject matter expert role for all functional areas.
- Maintains Process, Software and Product Risk Analysis to 14971:2012 requirements.
- Drives effective and efficient improvement of inspection and test methods, sampling plans, and process control plans.
- Prepares and conducts training sessions and presentations in support of quality objectives. Supports the Director, RAQA for Client Satisfaction processes and Business impact.
- Actively participates in new product development teams and design change activities.
- Supports all facets of the internal audit system including scheduling, auditing, reporting, and corrective actions.
- Maintains a professional working relationship with internal and external customers and support staff.
- Actively manage and/or support and develop the Inspection Team, Regulatory Specialist, and others as needed
- 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
- 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
- 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!
- Bachelor’s degree (B.S.) in engineering from a four-year college or university.
- Minimum of seven years experience in Regulatory and quality systems in an FDA-regulated industry.
- Four years of people management experience. Track record of building and leading high-performance teams
- Working knowledge of Quality Management Systems – 21 CFR Part 820, ISO 9001/13485, ISO 14971, ISO 17025 in development and manufacturing environments.
- Formal training in quality engineering body of knowledge and tools, Certified RAPs, and/or Quality Engineer desired.
- Demonstrated ability to lead, grow in a Leadership position, and enable Team members to grow as well.
- Marked ability to learn new applicable standards, determine how they apply to the Business and provide related guidance cross-functionally.
- 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.
- Ability to interpret trends and data, translating the information into actions, outcomes, and improvements
- Excellent documentation skills, with a solid process orientation and effective attention to detail
- 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.
- Great colleagues who are passionate about their work
- A possibility to learn about and follow interesting products from birth to re-birth
- Make a change: we save lives by reducing radiation!
- A global organization