Katalyst Healthcares and Life Sciences
Responsibilities:
- Support all elements of manufacturing quality systems, including new process qualifications, process re-evaluation, non-conforming material containment, root cause analysis, and corrective/preventive actions.
- Collaborate with plant quality leaders to identify best practices and implement standard work aimed at improving quality results.
- Provide quality support for existing product lines and facilities, including Engineering Change Control, process, and product improvements.
- Lead efforts to improve internal quality processes such as incoming inspection, claims handling, and process monitoring, ensuring compliance with ISO 9001:2015 certification standards.
- ct as the department liaison for new product development initiatives, participating in product design reviews, Advanced Quality Planning (AQP), FMEAs (Failure Modes and Effects Analysis), mistake proofing, and other related activities.
- Develop and maintain internal technical specifications and testing methods based on part complexity and tolerance sensitivities.
- Conduct product and process reviews related to warranty claims or customer complaints, performing trend analysis, and establishing quality metrics.
- Perform regular audits of manufacturing processes to ensure compliance with corporate standards.
- Engineering Degree or equivalent experience required.
- 5+ years of experience in a global Manufacturing, Quality, or Engineering role.
- Green Belt certification required (Black Belt is a plus).
- Experience in auditing quality systems and processes.
- Candidates must provide examples of how they approached and solved real-world quality challenges, including which problem-solving methods were used.
- Expertise in Statistical Process Control (SPC) and statistical methods (e.g., control charts, process capability). Familiarity with advanced statistical techniques is a plus.
- Proficient in MS Office and Minitab; experience with SolidWorks is a plus.
- SQ CQE and/or CSSBB certification is desired, but not required.
- Strong communication skills and the ability to effectively advocate - and stand firm - for quality measures with different facilities within the organization.