Position scope/summary

The Manager of Quality Assurance shall be responsible for the implementation, maintenance of and improvement to our client's Quality System program. The elements of the Quality System program shall be appropriately defined and implemented to ensure compliance to product quality, customer expectations and regulatory requirements.

Position Requirements

• Ensure appropriate procedures and policies are implemented to demonstrate compliance to FDA Quality System Regulations (Title 21, CFR, part 820) and other regulatory requirements.
• Ensure appropriate procedures and policies are implemented to demonstrate compliance to applicable Quality System standards. This includes, but is not limited to, ISO 13485:2016, and JPAL MHLW Ordinance 169.
• Fulfill the requirements and expectations as Management Representative. This shall include, but is not limited to corresponding with regulatory agencies, third party auditors, customers and the corporate office.
• Provide guidance and direction to Quality Assurance functions that will proactively prevent product or system non-conformances. Evaluate and implement improvement changes as needed.
• Oversee Quality Control personnel and activities to ensure that product manufactured by [Insert Client Name] meets all specified requirements. Evaluate and implement improvement changes as deemed necessary.
• Ensure appropriate procedures and policies are implemented to instill cross-functional department relationships. This includes, but is not limited to, Quality, Engineering and Operations.
• Establish and maintain a department budget, as required.
• Manager, Quality Assurance has the acting role of the Engineering Manager for MHLW Ordinance 169.
• Facilitate management review meetings. This shall include, but is not limited to, the reporting of customer complaints/issues, product non-conformances, internal audit observations, Corrective and Preventative actions.
• Conduct complaint investigations and failure analysis as deemed necessary.
• Conduct internal auditing and generate corrective actions as deemed necessary.
• Correspond with customers and vendors.
• Review and approve document changes and releases.
• Authorize expenditures for supporting basic Quality Assurance/Quality Control functions.
• Provide Quality System Regulatory and ISO training.
• Travel and participate in corporate directed projects/activities as deemed necessary.

Special projects

Qualifications

• Minimum of 5 years in a quality management position, preferably in a medical device or other FDA regulated industry. Working knowledge with FDA and other regulatory agencies, notified bodies, and ISO registrars. Must demonstrate excellent written and verbal communication skills.
• Working knowledge in a “controlled environment” setting. Advanced computer skills for database management, report generation and report writing. Previous experience in plastic injection molding related environment.
• Specialized Knowledge: Knowledge and understanding of Six Sigma, lean manufacturing, TQM and SPC applications. Desired candidate will have prior work history in packaging, MSA, SPC, Mini-tab, Infinity, sterilization, & clean room environment.

Education

• Bachelor’s degree in engineering, Microbiology, or equivalent.
• Postgraduate certification in a Quality Management discipline will be accepted

Environmental working conditions

Standing, sitting, walking, computer work and lifting.

About the job

New employees are eligible for the following benefits effective date of hire!

• Medical, dental, and vision benefits
• Company-paid life insurance and disability benefits
• Generous Paid time off and 10 paid Holidays
• 401k Plan with Company Match
• Tuition Reimbursement