Quality Assurance Manager

4 weeks ago


Cambridge, United States Ronin Staffing, LLC Full time $53 - $58
Job DescriptionJob Description

HERE’S THE JOB DESCRIPTION:
Title: 
Quality Assurance Manager #13094
Pay Rate: up to $58/hr
Location: Cambridge, MA 02138
Length: 1 year contract + Possible extension

Hybrid Schedule - Must be onsite at least 2 days per week
M-F: 8am - 5:00pm (flexible)

Top Must Have Skills:

  • Project Management
  • Experience with medical devices
  • Methods and equipment validation
  • Quality mindset



Job Details:

  • This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments.
  • Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
  • The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments, provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities.
  • The Quality Assurance Manager will also provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.


Responsibilities:

  • Work cross-functionally and globally with individuals and project teams within Combination Product Operations Quality groups and their stakeholders in Marketing, Operations, and Development
  • Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required.
  • Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes.
  • Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods.
  • Provide comprehensive quality guidance and advice to counterparts and stakeholders.
  • Provide Quality oversight of quality records such as Deviations, CAPAs, Change controls and review/approval of physical test methods documents.


Qualifications:

  • BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries
  • 8 years current experience with engineering processes/procedures and quality tools. - Major contributions to or the leadership of projects from development through the 510k and PMA approval process.
  • Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA.
  • Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions.
  • Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience.
  • Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting
  • Experience with Deviations, CAPAs, Change controls and document review/approval
  • Strong critical thinking, problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.


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