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Barry-Wehmiller · 1 day ago

Senior Quality Engineer

Boston, MA

Full-time

Hybrid

Senior Level, Lead/Staff

10+ years exp

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology. They are seeking a Senior Quality Engineer to join their Design Group, where the role involves providing quality solutions and leadership in regulatory compliance for clients in various industries.

Machinery

Responsibilities

Responsible for day-to-day communication, coordination, and organization of onsite project execution activities

Provide leadership and mentorship to other professionals

Provide customized Quality solutions to clients with challenging and unique needs

Provide direction and guidance to clients and other professionals with regards to Quality Systems, Change Management, Investigations, and/or Process Improvement initiatives as defined by DG’s clients

Provide review and comments to other professionals regarding Quality impacting deliverables

All Design Group Project Managers have leadership skills and experience in Life Science Project Management and have a drive and desire to grow and expand local and regional clients

Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

Qualification

Quality EngineeringFDA RequirementsCGMPsProject ManagementValidation ActivitiesTroubleshootingPharmaceutical ExperienceBiotech ExperienceMedical Device ExperienceTechnical DegreeCommunication SkillsLeadership

Required

Minimum 10 years of quality engineering or management experience

Must have experience managing and maintaining schedules and coordinating professionals

Must have experience developing Project Plans and Execution Strategies

Must have experience leading investigations and troubleshooting issues

Must have strong computer, written, and verbal communication skills

Pharmaceutical, Biotech and/or Medical Device project experience is required

Strong knowledge of FDA requirements, cGMPs, and standard QMS procedures is required

Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc

B.S. in Engineering, Chemistry, Microbiology, or related technical degree

Equivalent years of experience in as a Project Manager or Quality Engineer can be substituted for degree