25 Quality Assurance Manager - (JP10466) Jobs in Cambridge, MA
3 Key Consulting is Hiring a Quality Assurance Manager - (JP10466) Near Cambridge, MA
- 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.
- 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.
- Project management skills
- Experienced with processes involved in test, inspection for a wide range of devices, raw material components, constituent parts (needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems.
- Experience with quality records
- Experience with physical method validation, qualification and transfers
- Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs
- Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods
- Review and approve physical test method design documents, validation, qualification and transfer documents
- Review and approve quality records (deviations, CAPA/EVs, change controls)
- Lead problem solving and lean improvement projects.
- Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering 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.
Phone interview followed by panel interviewWe invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Job Summary
Full Time
Business Services
$118k-147k (estimate)
12/13/2023
05/09/2024
3keyconsulting.com
WEST HILLS, CA
100 - 200
2009
Private
$50M - $200M
Business Services
Related Companies
The job skills required for Quality Assurance Manager - (JP10466) include Quality Assurance, Leadership, Problem Solving, Process Improvement, Project Management, Commitment, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Manager - (JP10466). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Manager - (JP10466). Select any job title you are interested in and start to search job requirements.
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