Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- Develop and implement product and process quality control plans.
- Lead investigations of customer complaints, returns, and nonconformances.
- Conduct inspections, First Article and PPAP submissions, and support audits.
- Administer corrective and preventive actions (CAPA) and verify effectiveness.
- Use data-driven methods (SPC, Six Sigma) to identify and implement improvements.
- Partner with internal and external stakeholders to meet quality and compliance goals.
Requirements:
- Bachelor's degree in engineering required.
- 3 5 years' experience in quality engineering or manufacturing.
- Knowledge of ISO 9001:2015 (auditing experience required).
- Familiarity with IPC 620; AS9100 or ISO 13485 experience a plus.
- Strong skills in root cause analysis, CAPA, and statistical tools.
- ERP/MRP and Microsoft Office proficiency.
- Preferred: ASQ CQE, Internal Auditor certification, industry experience in aerospace, military, or medical devices.
Required Skills/Abilities:
- Strong analytical and problem-solving skills with attention to detail.
- Excellent verbal and written communication, including technical reporting.
- Ability to interpret engineering drawings and technical documentation.
- Effective project and time management skills with ability to handle multiple priorities.
- Skilled at cross-functional collaboration and influencing teams toward quality objectives.
- Ability to work independently and lead investigations with minimal oversight.