With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
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Job OverviewProvide Principal Quality Assurance level support and oversight to Corrective and Preventive Action (CAPA) activities and other activities within the Quality Compliance department. Mentor cross functional teams and other Quality Assurance Engineers. Facilitate activities to ensure effective and timely CAPAs. Drive continuous improvement activities.
Job Responsibilities and Essential DutiesCAPA (85%)- As a CAPA Coordinator, provide principal level expertise support and oversight to CAPA activities to ensure effective and timely CAPAs.
- Guide cross-functional teams through the CAPA request/CAPA process.
- Lead and mentor cross-functional teams and facilitate activities.
- Provide project manager support to ensure CAPA activities and timelines are agreed upon, communicated, managed, and met.
- Ensure CAPA Request and CAPA activities are performed per procedures and regulations.
- Drive problem definition and scoping of CAPAs to assure that the CAPAs appropriately address underlying issues.
- Lead and/or facilitate investigations and root cause analyses.
- Guide teams in documenting Effectiveness Check criteria.
- Perform CAPA Verification of Implementation and Effectiveness Check activities.
- Process CAPA documentation within the electronic systems.
- Serve as a facilitator and/or delegate for the CAPA Review Board as needed.
- Communicate reminders and CAPA actions needed to personnel at all levels within the organization.
- Drive continuous improvement activities within the CAPA process.
- Update procedures and other documentation as needed to ensure continued compliance with regulations.
- Develop and perform CAPA System training.
- Mentor junior level engineers.
Quality Compliance (10%)- Execute tasks and projects that impact the Quality Management System (QMS) as required.
- Perform analysis on a new or revised standard and execute deliverables to support continuous compliance to applicable current standards and regulations.
- Perform Verification of Implementation (VOI) and Effectivity (VOE) of corrective actions.
- Improve and maintain the QMS in line with ISO 13485, Medical Device Regulation (EU-MDR), MDSAP International Regulations (Australia, Brazil, Canada, Japan, USA) and regulatory requirements applicable to the Quality Management System Regulation (QMSR).
Other (5%)- Assist in meeting departmental goals and special projects as assigned.
- Support external audits in various roles as assigned: scribe, backroom technical support and file preparation.
- Prepare documentation needed to fulfill requests from customers (internal and external).
- Perform other duties, as assigned.
Minimum Requirements- Bachelor's Degree or Master's Degree in Engineering or Science, or equivalent work experience.
- Minimum 8 years' related experience working in medical device industry or other highly regulated industry, or equivalent.
Required Knowledge, Skills and Abilities- Expertise in CAPA (Corrective & Preventive Action) systems and root cause analysis.
- Demonstrated ability to lead, motivate, and provide guidance to cross functional project teams to resolve quality-related issues in a timely and effective manner.
- Excellent problem-solving skills combined with technical understanding and knowledge of products.
- Strong organizational, project management, and leadership skills.
- Ability to prioritize and manage key deliverables in a fast-paced environment.
- Must be able to handle multiple responsibilities concurrently.
- Excellent verbal and written communication skills.
- High level of attention to detail and accuracy.
- Strong understanding of Quality System processes, ISO 13485, ISO 14971, and FDA requirements, including: NCR, supplier controls, process controls, design controls, verification and validation, risk management systems, and other quality practices.
- Strong computer skills, including MS Office applications (Word/Excel/Power Point/Outlook/Teams) and statistical software are required. Ability to analyze data and interpret results.
Supervision/Management Of Others:Internal and External Contacts/Relationships- Interaction with all levels of personnel from various functions
- Interaction with cross-functional teams/departments
- Interaction with representatives from regulatory agencies and bodies
Environmental/Safety/Physical Work Conditions- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
- May work extended hours during peak business cycles.
- Hybrid office environment (works onsite and remotely).
- Occasional work in controlled environment.
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About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
