What are the responsibilities and job description for the Quality Manager position at Precision Optics Corporation Inc?
Job Description
Job Description
Description : Overview
The Quality Manager, reporting to the Director of Quality Assurance & Regulatory Affairs, is responsible for leading and managing the development, implementation, maintenance, and evaluation of quality systems and processes in our MA and ME facilities. Oversees production and supplier quality management activities. Responsible for ensuring that quality practices comply with applicable standards, regulations, and procedures.
Please note that relocation assistance is not available for this position.
Principal Responsibilities
- Evaluate production operations to ensure that products meet quality, integrity, functionality, and other specifications and requirements.
- Ensure the effective use of QMS systems including CAPAs, customer complaints, NCRs / MRB, change management, training, supplier management, deviations, preventive maintenance, and calibration.
- Implement Quality Control objectives, metrics, KPIs, and reporting to monitor production quality and post-sale product performance and identify continuous improvement opportunities.
- Ensure departmental compliance with the QMS, FDA QSR, ISO13485, ISO9001, and other regulatory requirements.
- Prepare product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Monitor supplier performance; evaluate and improve supplier auditing and monitoring processes.
- Oversee internal quality audits and develop corrective action plans to address findings; support external audits.
- Oversee documentation control activities & tools; ensure QC documentation such as checklists, logs, and reports are effective, and accurate.
- Participate in new product introduction and transfer to production activities, including providing feedback for continuous improvement.
- Foster a collaborative and high-performance quality culture based on continuous improvement principles to help improve quality, reduce costs, and increase customer satisfaction.
- Collaborate cross-functionally to develop training methods and training effectiveness.
- Ensure individual and team goals align with corporate strategic objectives.
- Perform miscellaneous duties and projects as assigned and required.
Working Conditions
This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms. PPE required when in controlled environment rooms or cleanrooms.
Physical surroundings
This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets.
Physical Effort
While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.
Work Schedule / Travel
In-person, Mon to Fri in Gardner, MA; occasional travel, with periodic presence in the Windham, ME site.
Other Requirements
Applicants must have US citizenship or US person status.
Requirements :
Training, Skills, Knowledge and / or Experience
Competencies
Education Requirements
Bachelor’s degree in Engineering or a related technical / science field; or an equivalent combination of education and experience.
