Share this Job
Apply now »

Engineer II, Design Quality (Hybrid) - Merrimack, NH

Date:  Jan 7, 2023
Location: 

Merrimack, NH, US

Company:  Getinge
Position Eligible for Remote Work:  1-2 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.

 

Job Function Summary: Support product development teams throughout the development process.


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 product complaints.
•    Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation.
•    Ensure the use of statistically valid sampling techniques.
•    Author the Quality, Risk and Usability sections of Design Control Quality Plans (DCQP).
•    Represent Quality initiatives and compliance when participating and Design and Phase reviews.
•    Remediate legacy products and documentation as required.


Required Knowledge, Skills and Abilities: 
•    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.  
•    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.


Quality Requirements
•    Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
•    Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
•    Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
•    Attend all required Quality & Compliance training at the specified interval.
•    Adopt the “Beyond Compliance Quality Culture” in the work environment; always meet and exceed 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.

#LI-DV1

 

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. 

Apply now »