Quality Director
Confidential Confidential Rochester, NY Rochester, NY Full-time Full-time $115,000 - $160,000 a year $115,000 - $160,000 a year 6 days ago 6 days ago 6 days ago Provide leadership in achieving the highest level of manufacturing quality of medical devices and quality system performance while ensuring compliance with all company policies and procedures.
Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system requirements.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.
Responsibilities:
Lead the Quality Management System supporting manufacturing process development and operations while ensuring compliance with all regulatory requirements including US FDA, State, OSHA, and international medical device regulations based on ISO 13485 quality system requirements.
Provide leadership for business process excellence and foster a culture founded upon Lean Management and Six Sigma principles and practices to drive customer value through continuous improvement.
Serve as the business Management Representative to maintain a culture of compliance and excellence.
Ensure the integration of risk-based thinking throughout business processes to support decision-making.
Work with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented work force.
Provide leadership for workforce education and development within Quality.
Develop, implement, communicate, and maintain quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
Oversee all Quality functions including documentation and training, customer feedback, nonconformances, CAPAs, supplier quality management, QC Inspection, and final product release.
Manage and maintain the Company's internal quality audit program and assess improvement initiatives resulting from all Quality Audits - internal and external.
Ensure individual performance and business process performance meets established goals and objectives.
Establish, follow, and improve company procedures as needed to maintain compliance and meet business goals and objectives.
Provide written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results.
Maintain a cooperative and motivational attitude with co-workers.
Perform other tasks as requested by supervisor to meet business goals and objectives.
Adhere to all Company policies, rules, procedures, and housekeeping standards.
Experience:
Minimum of 5 years of experience leading Quality Assurance / Quality Systems with experience in FDA and CE Notified Body inspections.
At least 10 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry.
Lean and Six Sigma experience with a proven track record of business performance improvement and personnel development.
Broad knowledge of manufacturing process control and validation.
Knowledge of measurement systems and inspection process management.
Understanding of ISO and other applicable standards.
Exposure to shop environment such as noise, dust, odors and fumes.
Direct supervision of quality department employees in a manufacturing facility.
Other skills, abilities, or certifications:
Experience with manufacturing process quality, process controls plans and validation, CNC machining and finishing operations, and inspections systems is preferred.
US FDA cGMP and ISO 13485 knowledge preferred.
Manufacturing plant safety.
Computer proficiency with MS Office and statistical analysis tools is required.
Multi-discipline assurance background is desired with emphasis on problem solving and continuous improvement through work force engagement and development.
ASQ certification or equivalent preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma).
Must be able to make solid decisions that effectively support the business and company policies.
Travel requirements are as needed.
Presentation skills and ability to train personnel in Quality and Regulatory Compliance.
Other Duties:
Please note thisis not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with or without notice.
Job Type:
Full-time Pay:
$115,000.
00 - $160,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
Lead and enforce regulatory compliance with US FDA, State, OSHA and international medical device regulations and ISO 13485 quality system requirements.
Responsible for development, implementation, and continual improvement of quality systems and procedures supporting manufacturing operations, supplier management, documentation and records, training, quality management, and auditing.
Responsibilities:
Lead the Quality Management System supporting manufacturing process development and operations while ensuring compliance with all regulatory requirements including US FDA, State, OSHA, and international medical device regulations based on ISO 13485 quality system requirements.
Provide leadership for business process excellence and foster a culture founded upon Lean Management and Six Sigma principles and practices to drive customer value through continuous improvement.
Serve as the business Management Representative to maintain a culture of compliance and excellence.
Ensure the integration of risk-based thinking throughout business processes to support decision-making.
Work with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented work force.
Provide leadership for workforce education and development within Quality.
Develop, implement, communicate, and maintain quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
Oversee all Quality functions including documentation and training, customer feedback, nonconformances, CAPAs, supplier quality management, QC Inspection, and final product release.
Manage and maintain the Company's internal quality audit program and assess improvement initiatives resulting from all Quality Audits - internal and external.
Ensure individual performance and business process performance meets established goals and objectives.
Establish, follow, and improve company procedures as needed to maintain compliance and meet business goals and objectives.
Provide written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results.
Maintain a cooperative and motivational attitude with co-workers.
Perform other tasks as requested by supervisor to meet business goals and objectives.
Adhere to all Company policies, rules, procedures, and housekeeping standards.
Experience:
Minimum of 5 years of experience leading Quality Assurance / Quality Systems with experience in FDA and CE Notified Body inspections.
At least 10 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry.
Lean and Six Sigma experience with a proven track record of business performance improvement and personnel development.
Broad knowledge of manufacturing process control and validation.
Knowledge of measurement systems and inspection process management.
Understanding of ISO and other applicable standards.
Exposure to shop environment such as noise, dust, odors and fumes.
Direct supervision of quality department employees in a manufacturing facility.
Other skills, abilities, or certifications:
Experience with manufacturing process quality, process controls plans and validation, CNC machining and finishing operations, and inspections systems is preferred.
US FDA cGMP and ISO 13485 knowledge preferred.
Manufacturing plant safety.
Computer proficiency with MS Office and statistical analysis tools is required.
Multi-discipline assurance background is desired with emphasis on problem solving and continuous improvement through work force engagement and development.
ASQ certification or equivalent preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma).
Must be able to make solid decisions that effectively support the business and company policies.
Travel requirements are as needed.
Presentation skills and ability to train personnel in Quality and Regulatory Compliance.
Other Duties:
Please note thisis not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities and activities may change at any time with or without notice.
Job Type:
Full-time Pay:
$115,000.
00 - $160,000.
00 per year
Benefits:
401(k) Dental insurance Health insurance Health savings account Life insurance Paid time off Tuition reimbursement Vision insurance Schedule:
8 hour shift Day shift Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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