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Engineer II, Quality Operations 2nd Shift (Onsite) - Merrimack, NH

Date:  Jan 11, 2023
Location: 

Merrimack, NH, US

Company:  Getinge
Position Eligible for Remote Work:  0 days
Salary Range: 

 

 

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.

 

2nd Shift Hours:  2:30 pm to 11:30 pm - This is a fully onsite position.

 

Job Function Summary:
The Production Quality Engineer will support production teams throughout the lifecycle of product.

 

Job Functions: 
•    Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
•    Provide expertise is risk management and analysis techniques when facilitating completion of FMEAs within a cross-functional team.
•    Evaluate risk during review of NCR’s.
•    Participate in Process Validation and Design Transfer activities.
•    Participate in the development of Production Master Control plans (PMCP).
•    Ensure the use of statistically valid sampling techniques.
•    Responsible for working with Operations to ensure compliance, cleanliness, and safety on the floor.
•    Develop, install, and provide support for maintenance of control charts on the floor. 
•    Remediate legacy products and documentation as required.
•    Contributes to the team effort by accomplishing related tasks as necessary.
•    Participates and leads CAPA’s as needed.

•    Evaluate verification and validation protocols and reports to ensure compliance to external standards and internal standards and procedures.
•    Provide expertise is risk management and analysis techniques when facilitating completion of FMEAs within a cross-functional team.
•    Evaluate risk during review of NCR’s.
•    Participate in Process Validation and Design Transfer activities.
•    Participate in the development of Production Master Control plans (PMCP).
•    Ensure the use of statistically valid sampling techniques.
•    Responsible for working with Operations to ensure compliance, cleanliness, and safety on the floor.
•    Develop, install, and provide support for maintenance of control charts on the floor. 
•    Remediate legacy products and documentation as required.
•    Contributes to the team effort by accomplishing related tasks as necessary.
•    Participates and leads CAPA’s as needed.

 

Required Knowledge, Skills and Abilities: 
•    Good analytical and problem solving skills.  
•    High level of attention to detail and accuracy. 

 

Minimum Requirements:  
•    Bachelor’s Degree in Engineering or Science, or equivalent work experience. 
•    A minimum of two years related manufacturing experience in a QMS environment.  
•    Strong computer skills, including MS Office applications (Word/Excel) and statistical software are required.
•    Knowledge of Quality Assurance methods, such as process validation, design of experiments, statistical process control (SPC) and protocol/report preparation.  
•    Knowledge of ISO 13485 and FDA requirements.  

 

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.

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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. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. 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 medtech company.

Apply now »