Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & 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.
Act 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.
Requirements:
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.
ASQ 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.