QA/RA Project Manager
DeepHealth
Quality Engineer II
Integer Holdings Corporation
full-time
Posted on:
Location Type: Office
Location: New Ross • 🇮🇪 Ireland
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support the Life Sciences group in one or more areas: sterilization, environmental monitoring, product cleanliness, and biocompatibility
- Ensure Integer’s Life Science requirements are met or exceeded with occasional direction and guidance
- Continue to learn application of microbiological and biocompatibility concepts in medical device manufacturing
- Adhere to Integer’s Values and safety, environmental, security and quality requirements including QMS, FDA regulations, company policies and procedures
- Review and apply applicable standards and procedures to support sterilization, environmental monitoring, product cleanliness, and biocompatibility
- Write and review protocols, reports, and other documents related to sterilization, microbiological test methods, and/or biocompatibility
- Perform technical project work following Integer’s quality management, production system and/or laboratory methodologies to evaluate, maintain and improve medical device quality
- Apply standard data analysis practices under guidance to establish root cause for out of specification results and support justifications for improvements
- Collaborate with others, ask questions, and confirm understanding with Life Science mentors to support development
- Provide/lead support for Quality and Manufacturing Excellence imperatives including corrective and preventive actions, Quality KPIs, Hoshin plans, validation master plans, QA RA metrics, sustained change and continuous improvement activities
- Support standardization via workplace organization & visual controls (5S), Manufacturing Standard Work, and training & certification programs
- Promote associate engagement through standardized problem solving, behavior-based safety programs, and improvement idea systems
- Report to Quality Manager or Senior Manager, Global Life Sciences
- Perform other duties as needed and as directed by line of supervision
Requirements
- You have earned, as a minimum, a bachelor’s degree in Biology, Microbiology, or related technical field
- At least 3 years of experience
- If you do not meet the education requirements, you may be considered with 7+ years of relevant experience
- Ability to work independently and collaboratively with other associates and cross functional teams
- Demonstrate a solid technical aptitude and ability to be an effective contributor to the team or produce technical results individually
- Demonstrate competencies in both written and oral communication
- Maintain a calm demeanor that transcends the high energy, constantly changing product environment
- Possess a positive, can-do attitude with an underlying belief that failure is not an option
- Ability to work in laboratory and production areas including cleanrooms with gowning requirements and high noise levels
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
microbiological conceptsbiocompatibilitysterilizationenvironmental monitoringdata analysisquality managementproduction system methodologiestechnical project workprotocol writingreport writing
Soft skills
collaborationcommunicationproblem solvingpositive attitudeindependenceteamworkadaptabilitycalm demeanorengagementleadership
