Description
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
Responsibilities:
- Support the development of new or improved In Vitro Diagnostics products and Laboratory Developed Tests as core team Design Quality Engineering lead; providing collaborative, solution-oriented technical guidance and support to the team
- Assist in the determination of appropriate deliverables and generating project timelines.
- Supports the sustainability and life cycle management of existing products
- Ensures compliance with quality system and regulatory requirements related to product and process
- Provide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development
- Evaluate adequacy of specifications for new or modified process designs.
- Support product and customer requirement definition and development
- Participate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.
- Recommends design or test methods and statistical process control for achieving required levels of product reliability.
- Reviews and analyze performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Performs design change control activities including impact assessments, reviews, and approvals
- Takes lead role in CAPA, non-conformances, and planned deviations activities such as investigation, implementation, or verification of effectiveness as required
- Supports risk management activities in collaboration with the Risk Manager as they relate to product development and post market surveillance requirements
- Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities)
- Support development master validation plans and reports.
- Provide technical support (subject matter expert) during audits (internal and third-party)
- Prepare documentation to support design history files and regulatory submissions ensuring documents are complete and accurate
- Maintain DHF and Propose, plan and execute improvement projects, as required for product sustainability
- Develop/update departmental procedures and other controlled documents.
- Participate in Material Review Board (MRB) and Change Review Board meetings, as required.
- Train and mentor new employees. Provide guidance and direction to the team.
- Plans, executes, and works with minimal supervision and independent judgment
Qualifications:
- Must have experience working with all classes of Medical devices preferably IVDs in a QE role. Previous CDx experience a plus
- Ability to demonstrate proficiency in design of experiments, IVDD/IVDR requirements, Risk management file generation and remediation, problem analysis and resolution.
- Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations and Change controls.
- Extensive cross-functional team experience, including technical and non-technical work.
- Strong interpersonal and communication skills.
- Strong leadership skills and ability to work in a team environment
- Highly motivated hands-on engineer with a proven record of meeting timelines and goals
Education and Experience:
- B.S. degree in Degree in a chemistry, biology, or engineering discipline is a plus with 7+ years of experience working in a regulated environment in the in-vitro diagnostic, medical device, biotech or pharmaceutical industry.
- Advance knowledge of applicable regulations including: 21 CFR Part 820, ISO 13485, ISO 14971
- Experience with process validation, analytical methods validation, and equipment qualifications.
- Demonstrated success in delivering results on several technical challenges.
- Working knowledge of medical device domestic and international standards.
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