Michael Page
Quality Control Manager - Medical Device Manufacturing
Michael Page, Rochester, New York, United States, 14600
Opportunity for career growthCompetitive Base Salary & Bonus StructureAbout Our Client
We are partnered up with a Medical Device Manufacturing client located near Rochester, NY in their search to add a Quality Control Manager to the team due to growth. This position will report into the Director of Quality and will lead a team of 6-10 inspectors and operators. If you have managerial experience and have worked in the Medical Device industry please read on and apply to the Quality Control Manager - Medical Device Manufacturing job based near Rochester, NY.
Job Description
The Quality Control Manager - Medical Device Manufacturing will be responsible for the following:
Develop, implement, and manage quality control policies, procedures, and protocols to ensure compliance with regulatory requirements (FDA, ISO 13485, CE marking, etc.).Plan and oversee the QC activities across all stages of the product lifecycle (incoming materials, in-process, and final product inspections).Lead, mentor, and develop a team of QC inspectors, technicians, and engineers.Ensure appropriate training and continuous development of QC personnel to stay updated on industry best practices and regulatory changes.Oversee routine inspections and audits of raw materials, in-process materials, and finished products to ensure compliance with specifications.Manage the implementation of quality testing (functional, dimensional, and safety testing) for new and existing products.Ensure proper calibration and maintenance of QC equipment and tools.Maintain accurate and up-to-date documentation of QC activities, including inspection reports, non-conformance reports (NCRs), and corrective/preventive action plans (CAPAs).Lead internal audits and support external regulatory inspections.Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.Investigate and resolve quality issues, including non-conformances, product failures, and customer complaints.Implement corrective and preventive actions (CAPA) to address root causes of quality issues.Collaborate with cross-functional teams (engineering, manufacturing, regulatory, etc.) to implement process improvements and enhance product quality.Conduct risk assessments (e.g., Failure Mode and Effects Analysis - FMEA) and implement risk mitigation strategies.Monitor key quality metrics (KPIs) and develop strategies to reduce defects and improve production efficiency.Manage supplier quality control programs, including the qualification, monitoring, and auditing of suppliers.Ensure that all supplied components and materials meet the company's quality standards and regulatory requirements.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The ideal Quality Control Manager - Medical Device Manufacturing will have the following qualifications:
Bachelor of Science in Mechanical Engineering, Industrial Engineering, or a related field.Managerial experience required5+ years of experience within a Medical Device Manufacturing Company or a related industryDocument Control experience requiredISO 13485 knowledgeAbility to wear many hats and work in a fast paced environmentWhat's on Offer
The Quality Control Manager - Medical Device Manufacturing will be rewarded with the following:
Base Salary of $100,000-$125,000 depending on experienceBonus401K MatchHealth, Dental, VisionPTO
Contact
Erin McQuillan
Quote job ref
JN-092024-6547438
We are partnered up with a Medical Device Manufacturing client located near Rochester, NY in their search to add a Quality Control Manager to the team due to growth. This position will report into the Director of Quality and will lead a team of 6-10 inspectors and operators. If you have managerial experience and have worked in the Medical Device industry please read on and apply to the Quality Control Manager - Medical Device Manufacturing job based near Rochester, NY.
Job Description
The Quality Control Manager - Medical Device Manufacturing will be responsible for the following:
Develop, implement, and manage quality control policies, procedures, and protocols to ensure compliance with regulatory requirements (FDA, ISO 13485, CE marking, etc.).Plan and oversee the QC activities across all stages of the product lifecycle (incoming materials, in-process, and final product inspections).Lead, mentor, and develop a team of QC inspectors, technicians, and engineers.Ensure appropriate training and continuous development of QC personnel to stay updated on industry best practices and regulatory changes.Oversee routine inspections and audits of raw materials, in-process materials, and finished products to ensure compliance with specifications.Manage the implementation of quality testing (functional, dimensional, and safety testing) for new and existing products.Ensure proper calibration and maintenance of QC equipment and tools.Maintain accurate and up-to-date documentation of QC activities, including inspection reports, non-conformance reports (NCRs), and corrective/preventive action plans (CAPAs).Lead internal audits and support external regulatory inspections.Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulations and standards.Investigate and resolve quality issues, including non-conformances, product failures, and customer complaints.Implement corrective and preventive actions (CAPA) to address root causes of quality issues.Collaborate with cross-functional teams (engineering, manufacturing, regulatory, etc.) to implement process improvements and enhance product quality.Conduct risk assessments (e.g., Failure Mode and Effects Analysis - FMEA) and implement risk mitigation strategies.Monitor key quality metrics (KPIs) and develop strategies to reduce defects and improve production efficiency.Manage supplier quality control programs, including the qualification, monitoring, and auditing of suppliers.Ensure that all supplied components and materials meet the company's quality standards and regulatory requirements.MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The ideal Quality Control Manager - Medical Device Manufacturing will have the following qualifications:
Bachelor of Science in Mechanical Engineering, Industrial Engineering, or a related field.Managerial experience required5+ years of experience within a Medical Device Manufacturing Company or a related industryDocument Control experience requiredISO 13485 knowledgeAbility to wear many hats and work in a fast paced environmentWhat's on Offer
The Quality Control Manager - Medical Device Manufacturing will be rewarded with the following:
Base Salary of $100,000-$125,000 depending on experienceBonus401K MatchHealth, Dental, VisionPTO
Contact
Erin McQuillan
Quote job ref
JN-092024-6547438