Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
- The primary need is help with execution for equipment and process validation protocols.
- Role will work with the San Diego team and Ireland teams. Ability to manage different time zones and teams is very important.
- The ideal candidate will have less than 10 years of experience, not too senior but with solid experience in protocol development and execution.
- Experience with sensor equipment and/or Class II devices is a plus.
- One of the hiring managers can be picky and values strong personality to manage different time zones and take initiative with tracking down SMEs. Communication skills are very important. In addition to technical backgrounds, the HM will be trying to evaluate how they handle stress and the different time zones and communication styles of the global teams.
- Client is seeking a validation engineer to support the qualification and validation of a manufacturing line at our Ireland site. This engagement is critical to ensuring compliance with medical device standards and operational readiness for production. The consultant will work closely with cross functional teams across global sites, including SMEs, manufacturing and quality representatives, to execute Installation, Operational, and Performance Qualification (IOPQ) activities.
Responsibilities:
- Protocol Development & Execution.
- Update existing qualification and validation protocols or author new ones based on equipment/process requirements.
- Collaborate with SMEs to gather missing requirements and translate them into testable criteria.
- Write and align test cases with cross-site teams to ensure consistent execution.
- Quality System Navigation:
- Navigate Dexcom's complex Quality Management System (QMS), recognizing and adapting to special cases and exceptions.
- Ensure all documentation and activities comply with internal procedures and regulatory standards.
Execution Support:
- Expected to travel internationally to the Ireland site to support IOPQ execution.
- Participate in dry runs and live execution, collaborating with teams across time zones on equipment execution, material planning and test scheduling.
- Generate qualification reports using Dexcom-approved templates and support documentation approval process.
Communication & Collaboration:
- Maintain clear and timely communication with stakeholders across global sites.
- Provide regular updates and flag risks or delays proactively.
Expected Deliverables:
- Updated or newly authored qualification protocols.
- Executed IOPQ & PV documentation and reports.
- Weekly status updates and final summary reports.
Requirements:
- Minimum of 2+ years of experience in medical device qualification.
- Demonstrated ability to work within complex QMS environments.
- Strong technical writing skills and ability to synthesize input from multiple stakeholders.
- Willingness and ability to travel internationally.
- Comfortable working across time zones and cultures.
- International travel to Ireland site is required.
- Candidate must be able to obtain visa without sponsorship.
- Travel schedule will be coordinated with the Dexcom team based on project milestones.