Sustaining Design Quality Engineer

Job Post Index 21E776-Sy##
Location Westford, MA
Description: Job Description
  • Assures new or modified products conform to quality standards and establishes compliance with the quality system.
  • Build hardware and software
  • Lead the view in design and help with fixing the process.
  • Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
  • Execute and support on-time completion of Design Control Deliverables
  • Support on-time execution of Quality Plans for internal development, OEM-based and design change projects
  • Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
  • Lead or support Risk Management activities from product Concept through Commercialization
  • Support design test and inspection method development, and lead method validation activities
  • Ensure DHF content completion, integrity, and regulatory and standards compliance
  • Collaboratively communicating and resolving gaps
  • Support manufacturing process development and qualification for new product commercialization and product changes
  • Support internal and external audit responses
  • Support product re-certifications
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
  • Leads CAPA for design issues coming from manufacturing, complaints and improves design.
  • Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support execution of biocompatibility and sterilization qualifications
  • Complete Document Change Request Reviews in a timely and objective manner
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Skills: Qualifications
  • Minimum Bachelors degree in Engineering
  • 5 years experience in medical device industry with products meeting quality system requirement of ISO13485 and 21CFRPart 820 FDA as a Supplier Quality Engineer.
  • 5 years experience in material qualification, material specification development and supplier process validation
  • 5 years experience in finished good process validation, developing inspection test methods and equipment qualification
  • 5 years experience in driving supplier performance improvement through CAPA and performing root cause investigation
  • 5 years experience in data analysis (capability analysis in minitab, trending/pivot in Excel)
  • 5 years experience in supplier development, supplier KPI/performance measurement and demonstrated performance improvement
  • Strong leadership experience
  • Strategic thinker and knowledge of design controls.
  • Project management background preferred
  • Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications
  • Ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in timely manner.
  • Strong organizational and follow-up skills
  • Attention to detail.

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