Engineer, Quality
Job Title: Sustaining Design Quality EngineerJob Location: Westford Massachusetts, 01886Job Duration: 7 Months
MAIN RESPONSIBILITIESExecute and support on-time completion of Design Control DeliverablesSupport on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projectsAccountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activitiesLead or support Risk Management activities from product Concept through CommercializationSupport design test and inspection method development, and lead method validation activitiesEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport manufacturing process development & qualification for new product commercialization and product changesSupport internal & external audit responsesSupport product re-certificationsSupport the establishment of objective, measurable, discrete, and verifiable customer and product requirementsSupport objective component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport execution of biocompatibility and sterilization qualificationsComplete Document Change Request Reviews in a timely and objective mannerAdditional duties may be identified by functional management based on the current project/business objectives.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.
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Job Type:Contract
Location:Maynard, MADistance:11 miles
Date Posted:Apr 2, 20204 days ago
Industry:Pharmaceuticals
Job Title: Sustaining Design Quality EngineerJob Location: Westford Massachusetts, 01886Job Duration: 7 Months
MAIN RESPONSIBILITIESExecute and support on-time completion of Design Control DeliverablesSupport on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projectsAccountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activitiesLead or support Risk Management activities from product Concept through CommercializationSupport design test and inspection method development, and lead method validation activitiesEnsure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gapsSupport manufacturing process development & qualification for new product commercialization and product changesSupport internal & external audit responsesSupport product re-certificationsSupport the establishment of objective, measurable, discrete, and verifiable customer and product requirementsSupport objective component specification definitions, supplied component sampling plan development, and vendor qualificationsSupport execution of biocompatibility and sterilization qualificationsComplete Document Change Request Reviews in a timely and objective mannerAdditional duties may be identified by functional management based on the current project/business objectives.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.
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