Über
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.
Are you looking for an inspiring career? You just found it.
Job Overview
Provide Senior QualityAssurancelevelsupport andoversight toCorrective and Preventive Action(CAPA)activitiesand other activities within the Quality Compliance department.Mentorcross functionalteams andfacilitateactivities to ensureeffective andtimelyCAPAs. Drive continuous improvement activities.
Job Responsibilities and Essential Duties
(95%)
Asa CAPACoordinatorprovideseniorlevelquality assurancesupport and oversight to CAPAactivitiesto ensure effective andtimelyCAPAs.
Guide crossfunctional teams through the CAPA request/CAPA process.
Mentorcross functional teams andfacilitateactivities.
Provideprojectsupport toensure CAPA activities and timelines are agreed upon, communicated, managed, and met.
Ensure CAPA Request and CAPA activities are performed per procedures and regulations.
Guideproblem definition and scoping of CAPAs to assure that the CAPAs appropriately address underlying issues.
Facilitateinvestigations 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 facilitatorand/or delegate forthe CAPA Review Board as needed.
Communicate reminders & CAPA actions needed to personnel at all levels within the organization.
Leadcontinuous 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.
Other (5%)
Assistin meeting departmental goals and specialprojects asassigned.
Support external audits in various roles as assigned: scribe, backroom technicalsupportand file preparation.
Prepare documentation needed to fulfill requests from customers (internal and external).
Perform otherduties,as assigned.
MinimumRequirements
Bachelor's degree in engineering discipline or scientific discipline (e.g.Chemistry, Biology, Physics) or equivalent experience.
Minimum 3 years' experience with CAPA and root cause investigations.
Minimum 3 years' quality or equivalent experience, working in medical device industry or other highly regulated industry, or equivalent experience.
Required Knowledge,Skillsand Abilities
Strongcommunicationand organizational skills.
High levelof attention to detail and accuracy.
Expertiseusing root cause analysis techniques.
Ability to prioritize and manage key deliverablesandwork on multiple tasks/projects.
Knowledge of Quality Systems, ISO13485and FDA requirements.
Knowledge of CAPA, NCR, supplier controls, process controls, design controls, verification and validation, and risk management systems.
Strong computer skills, including MS Office applications (Word/Excel/Power Point/Outlook/Teams)and statistical softwarearerequired.Ability to analyze data and interpret results.
Supervision/ManagementOfOthers:
Not Applicable
Internal and External Contacts/Relationships
Interaction with all levels of personnel from various functions
Interaction with cross-functionalteams/departments
Interaction with representatives from regulatory agenciesand bodies
Environmental/Safety/Physical Work Conditions
Ensures environmental consciousness and safe practices areexhibitedin decisions.
Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
Hybrid office environment
May work extended hours during peak business cycles.
Occasional work in controlled environment
Annual salary of $95K-120K with 10% STIP
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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.
Sprachkenntnisse
- English
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