At Getinge we have the passion to perform
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.
Are you looking for an inspiring career? You just found it.
Quality Engineer provides technical support to internal teams (e.g. engineering, R&D, production) for the quality assurance function.
- Ensure Quality Systems is run by current regulation 21 CFR 820 and ISO 13485
- Work within Quality to assist in maintaining cGMP compliance for products manufactured, packaged, tested and released
- Work with R & D on new product launches and commercial projects and ensure they are in line with cGMP requirements
- Write and review investigations, CAPAs, NCs, SCARs, Change Notices, and any additional QA documentation functions necessary to run the business.
- Ensure adequate follow-up through the implementation of corrective and preventive actions as appropriate.
- Provide support to production for WIP on the manufacturing floor.
- Support Quality Management during audits and inspections.
- Strengthen quality awareness, throughout the organization, support technical services, and process improvements.
- Ensure that proper document control is handled for facility.
- Review protocols and reports as needed ensuring proper compliance to regulations.
- Support new product development activities through understanding and utilizing the New Product Development Systems. Key activities include quality strategy development, quality planning tools (FMEAs, Quality Plans, Validation Plans, etc.) and qualification/validation strategy development & execution.
- Chair and/or participate in MRB (Material Review Board) meetings.
- Evaluate new product designs through test protocols and data analysis
- Engage in associated manufacturing/quality process improvement/development support and perform/participate in qualifications/validation activities. Monitor progress using operational metrics and appropriate trending.
- Identify and assess new opportunities for improvements to work processes, product, and/or services.
- Coordinate technical activities regarding verifications and validations: including protocol development, synchronization of interdepartmental activities, data evaluation, report writing, and presentations to management.
- Review and provide recommendations regarding product/process qualification/validation and other change control related (CCRs) documentation prior to department management final approval.
- Communicate, interact, and coordinate quality improvement efforts with Production, QA, R&D, and training support to Production, Engineering and R & D.
Minimum Requirements
- A Bachelor’s degree in Engineering, Science or related fields or equivalent experience is required.
- One to three years of experience in quality assurance, quality engineering or related function is required or MS and at least one year of experience. Experience working in the medical device industry strongly preferred.
- Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations as applicable to the job function.
About us
Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. Our passionate people hold our brand promise ‘Passion for Life’ close to heart.
If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.
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.
Salary: $75-88k + bonus targeted at 8% depending on overall company performance
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