Quality Assurance Manager - JP10466
Quality Assurance Manager - JP10466
Posted on :
10-04-2025
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1 Vacancy
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Job Description
Job Title: Quality Assurance Manager (JP10466
Location: Cambridge MA. 02138
Employment Type: Contract
Business Unit: Combination Product Operations Quality Core
Duration: 4 months (with likely extensions)
Posting Date: 06/20/22
Notes: Only qualified candidates please.
3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
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:
Basic Qualifications:
Top MustHave Skill Sets:
Day to Day Responsibilities:
Red Flags:
Lack of any quality experience and/or device experience.
Interview process:
Phone interview followed by panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Location: Cambridge MA. 02138
Employment Type: Contract
Business Unit: Combination Product Operations Quality Core
Duration: 4 months (with likely extensions)
Posting Date: 06/20/22
Notes: Only qualified candidates please.
3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
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 microinfuser 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 crossfunctional teams to utilize technologies and methodologies that support shortcycle 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.
Basic 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//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.
Top MustHave Skill Sets:
- 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 microinfuser delivery pump systems.
- Experience with quality records
- Experience with physical method validation qualification and transfers
Day to Day Responsibilities:
- Work with a cross functional team to ensure compliance to design controls and fulfillment of user needs
- Work with crossfunctional 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 crossfunctionally 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 crossfunctional 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.
Red Flags:
Lack of any quality experience and/or device experience.
Interview process:
Phone interview followed by panel interview
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this particular position please feel free to take a look at the other positions on our websitewww.3keyconsulting/careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Manager
Employment Type
Full Time
Key Skills
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