Engineering Principal – Medical Device Design - Remote (JP9316)
Thousand Oaks, CA. (Remote position)
Final Product Quality and Surveillance
months with likely extensions.
3 Key Consulting is hiring an Engineer Principal – Medical Device Design
for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Candidate must have device design experience. This is a senior level role. The Principal Quality Engineer – Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products.
Why is the Position Open?
- Accountable for ensuring that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities.
- Independently manages high complexity programs with greater risk to the business including those which are novel or new to client, including electromechanical, and/or internally developed.
- Responsible to represent FPTQ Development in external engagements.
- Provides oversight of proper quality resource balancing on project(s) as required, ensuring FPTQ resources are proactively managed.
- Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout the design & development lifecycle, including content from suppliers and partners.
- Participates in definition and development of final product requirements, in particular for specialized products.
- Approves device components and final product or the device constituent of a combination product specification as part of development program.
- Establishes the quality requirements for development process to transfer design.
- Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases.
- Participates in non-design control investigations on an as needed basis.
- Responsible for creation, updating, and maintenance of Traceability Matrix. Develops and maintains final product quality plan. Quality approval at all key design phases (i.e. verification, validation, development, and launch readiness) and key participant at design reviews. Quality approver of the Design History File.
- Ensures that all Quality Requirements have been met and DHF is ready for Prior Approval Inspections (PAIs), Inspection Readiness Activities, and Partner Audits.
- Obtains, reviews, and confirms readiness of documentation for inspections. Ensure control strategies have been established, implemented, and maintained throughout the design and development lifecycle.
- Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ Development Quality as needed.
- Supports development of program-related quality agreements. Participates in generation of development agreements with third parties.
Supplementing additional workload on the current team.
Top Must-Have Skill Sets:
Employee Value Proposition:
- Medical Device Design Validation.
- Medical Device Design Verification.
- Quality experience including change control, design controls, risk assessment and management, and root cause analysis
- Looking for human factors experience as well.
Work with a team of industry experts at one of the top biopharmaceutical companies, assist with meaningful products that make lasting impacts.
No device experience.
No QA experience.
Video Skype Panel Interview
We invite qualified candidates to send your resume to firstname.lastname@example.org
. 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.