Merrimack, New hampshire
Senior Quality Assurance Engineer Job Opening in Merrimack, New hampshire - Job Functions :
CAPA Team Leadership
Act as project manager to ensure CAPA activities and timelines are agreed upon, communicated, managed, and completed/met
Ensure 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 failure investigations and root cause analyses
Guide teams in documenting Verification of Effectiveness criteria per procedure
Perform CAPA verification of implementation and verification of effectiveness activities
Support external audits in various roles as assigned: scribe, backroom technical support, file preparation, and auditor facilitator
Prepare documentation needed to fulfill requests from customers (internal and external)
Update procedures and other documentation as needed to ensure continued compliance with regulations
Perform other duties, as assigned
Required Knowledge, Skills and Abilities:
Great communication and organizational skills
Expertise in root cause analysis techniques
Demonstrated ability to manage projects involving cross-functional membership
Microsoft Office intermediate user of Word, Excel and Power Point
Minimum Requirements:
Bachelor?s degree in engineering discipline, or equivalent experience
Minimum 3 years experience with CAPA.
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.
Job Type: Full-time
Required experience:
medical device: 1 year
CAPA Leadership: 3 years
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