Quality Engineer - Design Assurance

Job description

Quality Engineer - Design Assurance

Your role:

The Quality Engineer - Design Assurance, will be responsible for providing quality assurance support for the development and introduction of new MilliporeSigma products and solutions. As a core team member of product development teams, you will be ensuring the timely delivery of quality products to market. You will also be responsible for seeing that MilliporeSigma is compliant with its quality system and design controls. This position reports to the Head of Quality at the Danvers, MA site.

·  Provide expert design assurance guidance and support for MilliporeSigma product, program, and solution development projects. Responsibilities to include:
·  Design control
·  Product and process validation planning and support
·  Risk management
·  Supplier assessments
·  Interface and coordinate activities with other quality functions such as manufacturing site quality, quality systems, regulatory affairs, external quality groups, etc…
·  Interface with and leverage the entire matrix organization at MilliporeSigma in order to best achieve organizational goals.

 

Who you are:

Basic Qualifications:

·  1+ years progressive, seasoned design assurance engineering within the biopharma or medical device industries
·  Bachelor's degree in related technical area (preferably engineering)
·  Full understanding of product and process validation
·  Demonstrated capability of applying risk management concepts and tools
·  Hands-on experience in the application of quality system standards
·  Experienced at working in cross-functional teams
·  Other necessary expertise:
·        Design control
·        Knowledge of quality and regulatory requirements
·        Development of solutions to complex problems
·  Must be able to multi-task and prioritize activities
·  Strong written and verbal communication skills (internal/external)
·  Strong teamwork and collaboration skills
·  Strong organizational skills
·  Willingness and ability to travel to MilliporeSigma’s suppliers or internal customer locations

 

Preferred Qualifications:

·  Other Desirable expertise:
·  ASQ Quality Engineer Certification (CQE)
·  Six Sigma Certification
·  Quality by Design
·  Applied/industrial statistics experience
·  GAMP5

 RSRMS

Job Requisition ID: 202152

Location: Danvers

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Boston
Job Segment: Medical, Product Development, QA, Quality Assurance, Quality, Healthcare, Research, Technology