Katalyst CRO
Overview
2 days ago Be among the first 25 applicants
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.
35 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.
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
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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.
35 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.
Seniority Level Associate
Employment Type Contract
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr