Development Quality Engineer

4 weeks ago

Westford, United States Planet Pharma Full time

• Manager is looking for a Supplier Quality Engineer who is comfortable speaking and working both on the line to determine if issue is material and speaking to the supplier/vendor regarding the issue to get it resolved. • Bachelor’s degree required, strongly prefer in Engineering • Minimum of 2 years of experience in manufacturing space working with suppliers/vendors. • Must be able to understand manufacturing so not looking for supplier “auditors”. Must be “Technical” who understand line manufacturing. • Process validation exp. with IQ, OQ and PQ a must • Must have a medical device background • Must be able to speak and work with suppliers/vendors. • Will be responsible for corrective action with suppliers/vendors • Process change management • Must have problem solving skills thru CAPA investigations

Top Priorities: • Medical device • Talk and work with Suppliers/vendors • CAPA

Years Experience: 2-5

Skills: Verbal and written communication, interpersonal, team work, individual contributor, multi task, strong organizational, advanced computer skills

Education: Bachelor level degree in an Engineering Discipline or other technical field experience

Duties: participate in or lead teams in supporting quality disciplines, decisions, and practices, lead on-time completions of design control deliverables, support on-time execution of Quality Plans for internal product development process (PDP), OEM-based Clinical Product Development (CPDP) and design change projects, accountable for generation of PDP design verification test plans/reports for product/system requirements, lead or support Risk Management activities from product concept through commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA's and Cybersecurity risk assessments, lead identification of essential outputs and generate Essential Output reports, accountable for completion of labeling verification activities and labeling verification reports, work with design engineering in the completion of customer/system/product requirements, work with design engineering in the completion of product verification and validation, endure DHF content completion, integrity and regulatory & standards compliance, collaborative communication resolving gaps, complete document change request reviews in a timely and objective manner, identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements, assist in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements, assist in tech development and execution of streamlined business systems which effectively identify and resolve quality issues, apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues, support all company initiatives as identified by management and in support of quality management systems (QMS), Environmental Management Systems (EMS) and other regulatory requirements, additional duties may be identified by functional management based on the current project/business objectives.

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