Quality Assurance Manager

SSI People
Thousandoaks, CA
18 Jul 2024

Vacancy expired!

Title:

Quality Assurance Manager

Location

:

Thousand Oaks

, CA

Contract: 13 Months

Job Details:
  • Provide 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.
  • The role of the Senior Quality Engineer is to 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.

Responsibilities:
  • 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.

Skills:
  • 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
  • Strong critical thinking, problem solving, risk assessment, and risk management skills.
  • Must be capable of working on multiple projects in a deadline driven environment.
Max Rate Not to Exceed (If this differs from the job posting template): (No Value)Why is the Position Open? Supplement additional workload on teamTop 3 Must Have Skill Sets: Process Improvement-Strong critical thinking, problem solving, risk assessment, and risk management skills.-BS in Engineering, with experience in Quality Assurance experience (2+)-medical device and/or pharmaceutical industries background, a plus not requirement- 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/DFMEADay to Day Responsibilities: Work with cross functional areas to achieve timelines for projects, method development, CAPAs, deviations, change control and others; in alignment with our SOPs and regulatory expectations.Employee Value Proposition: to work with a dynamic teamPossible Extension: YesRed Flags: No quality experienceEngineering background/degree or engineering experience, preference is Engineering degreeInterview Process: Panel interview - final
  • ID: #44186148
  • State: California Thousandoaks 91320 Thousandoaks USA
  • City: Thousandoaks
  • Salary: $60 - $70
  • Job type: Contract
  • Showed: 2022-07-18
  • Deadline: 2022-08-27
  • Category: Et cetera