Carwild Corporation
Overview
Carwild Corporation is seeking a Quality Manager to ensure product and process excellence across our organization. This role applies quality principles to resolve issues, support new and sustained product development, lead investigations, and maintain compliance with regulatory standards. You will work on diverse quality challenges related to Quality Systems, Product Quality, and Supplier Management.
Key Responsibilities
Ensure compliance with Quality System and regulatory requirements (ISO13485, ISO14971, FDA 21 CFR Part 820).
Support new and sustained product development, including supplier validation (IQ, OQ, PQ).
Act as QA representative for design control projects.
Lead complex complaint investigations using root cause analysis and corrective actions.
Apply risk analysis tools (FMEA, Hazard Analysis, Control Plans, Risk Management Reports).
Provide input for test protocols and statistical analysis of complaint data.
Develop sampling plans for inspections and production.
Support internal/external audits (FDA, ISO, customer assessments).
Assist with supplier development and qualification.
Deliver training on quality tools and procedures.
Prepare and file regulatory and quality documentation.
Qualifications
Education: B.S. in Engineering or related technical discipline (Chemistry, Biology, Physics, Mathematics).
Experience: Minimum 5 years in a regulated industry (medical device preferred; aerospace, automotive, pharmaceutical acceptable).
Skills: Proficient in QA methodologies (FMEA, SPC, Root Cause Analysis, DOE); Experience with validation (IQ, OQ, PQ); Strong statistical knowledge (SPC, Cpk/Ppk, AQL, OC curves) and tools like Minitab.
Familiarity with ISO 13485 and FDA GMP/QSR.
Supplier development and qualification experience.
Preferred: Professional certifications (CQE, CQA, Lean Six Sigma), continuous improvement program implementation, knowledge of EU MDR 2017/745.
What We Value Integrity, customer focus, compliance, and a commitment to quality excellence aligned with Carwild’s Guiding Principles.
Apply Today! Join us in shaping the future of quality and innovation. Submit your application to HR@carwild.net
#J-18808-Ljbffr
Key Responsibilities
Ensure compliance with Quality System and regulatory requirements (ISO13485, ISO14971, FDA 21 CFR Part 820).
Support new and sustained product development, including supplier validation (IQ, OQ, PQ).
Act as QA representative for design control projects.
Lead complex complaint investigations using root cause analysis and corrective actions.
Apply risk analysis tools (FMEA, Hazard Analysis, Control Plans, Risk Management Reports).
Provide input for test protocols and statistical analysis of complaint data.
Develop sampling plans for inspections and production.
Support internal/external audits (FDA, ISO, customer assessments).
Assist with supplier development and qualification.
Deliver training on quality tools and procedures.
Prepare and file regulatory and quality documentation.
Qualifications
Education: B.S. in Engineering or related technical discipline (Chemistry, Biology, Physics, Mathematics).
Experience: Minimum 5 years in a regulated industry (medical device preferred; aerospace, automotive, pharmaceutical acceptable).
Skills: Proficient in QA methodologies (FMEA, SPC, Root Cause Analysis, DOE); Experience with validation (IQ, OQ, PQ); Strong statistical knowledge (SPC, Cpk/Ppk, AQL, OC curves) and tools like Minitab.
Familiarity with ISO 13485 and FDA GMP/QSR.
Supplier development and qualification experience.
Preferred: Professional certifications (CQE, CQA, Lean Six Sigma), continuous improvement program implementation, knowledge of EU MDR 2017/745.
What We Value Integrity, customer focus, compliance, and a commitment to quality excellence aligned with Carwild’s Guiding Principles.
Apply Today! Join us in shaping the future of quality and innovation. Submit your application to HR@carwild.net
#J-18808-Ljbffr