Overview
Quality Engineer II Jobs in Whitesboro, NY at Pursuit Aerospace
Quality Control Manager
The Quality Control (QC) Manager is responsible for overseeing and managing all QC activities and leading the Quality Control team to ensure that Class II and Class III medical devices manufactured meet established quality standards and comply with applicable regulatory requirements. This individual leads the QC team in executing inspection, testing, and release activities, while supporting continuous improvement and maintaining alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
Organizational Competencies & Cultural Values:
The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.
Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.
General Competencies:
Knowledge of regulatory requirements including FDA regulations, ISO standards, and other applicable laws and guidelines.
Understanding of medical device lifecycle to ensure compliance and maintain quality standards throughout the development and manufacturing process.
Quality Control experience, including creating inspection methods, implementing inspections, testing, and validation methods to ensure that products meet predefined quality standards.
Risk management to identify and mitigate potential risks in the development and manufacturing processes.
Continuous process improvement by identifying inefficiencies and implementing improvement initiatives.
Strong leadership skills to motivate and guide the quality control team and other departments to ensure quality compliance within the company.
Effective communication with cross-functional teams, regulatory bodies, and both internal and external stakeholders.
All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Employees should take the initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.
Essential Job Functions:
Lead and manage the Quality Control department, including incoming inspection, in-process inspection, final product inspection, and testing.
Ensure timely and accurate execution of quality control activities to support production schedules and product release timelines.
Develop, implement, and maintain QC procedures, specifications, and sampling plans in accordance with regulatory and internal quality requirements.
Lead investigations of nonconformances (NCRs), deviations, and out-of-specification (OOS) results; collaborate with cross-functional teams on root cause analysis and corrective actions.
Monitor QC metrics and trends; report findings to senior management and recommend improvements.
Provide leadership, training, and development to QC staff to maintain a high-performing team.
Coordinate with manufacturing, engineering, and quality assurance to support continuous improvement and resolve quality issues.
Education and Experience:
Bachelor’s or master’s degree in engineering or a related field.
Minimum of 5 years’ experience in quality management in a medical device manufacturing setting.
Minimum of 5 years’ experience managing a team.
In-depth knowledge of medical device regulations, including FDA QSR and ISO 13485:2016.
Experience with Class III medical device development and manufacturing is strongly preferred.
Experience conducting internal and supplier audits.
Working knowledge of statistical process control, design control, and other quality tools.
Excellent problem-solving and analytical skills.
Strong communication and team collaboration skills
Ability to work in a fast-paced and dynamic environment.
Physical Demands:
Ability to sit or stand for long periods of time.
Ability to lift, bend or move up to 25 pounds.
Ability to adjust work schedule to meet deadlines and deliverables.
Compensation:
$109,000 to $150,000 Annually, depending upon experience
Paid Vacation
Paid Holidays
Paid Sick Leave
Partial Payment by Company of Group Health, Dental, and Vision Insurance
401(k) with limited company matching
Quality Control Manager
The Quality Control (QC) Manager is responsible for overseeing and managing all QC activities and leading the Quality Control team to ensure that Class II and Class III medical devices manufactured meet established quality standards and comply with applicable regulatory requirements. This individual leads the QC team in executing inspection, testing, and release activities, while supporting continuous improvement and maintaining alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
Organizational Competencies & Cultural Values:
The mission of every employee at Osypka Medtec is dedication to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.
Our vision is to be a leading medical company in the development, production, sale, and marketing of permanent and temporary devices and services around the world.
General Competencies:
Knowledge of regulatory requirements including FDA regulations, ISO standards, and other applicable laws and guidelines.
Understanding of medical device lifecycle to ensure compliance and maintain quality standards throughout the development and manufacturing process.
Quality Control experience, including creating inspection methods, implementing inspections, testing, and validation methods to ensure that products meet predefined quality standards.
Risk management to identify and mitigate potential risks in the development and manufacturing processes.
Continuous process improvement by identifying inefficiencies and implementing improvement initiatives.
Strong leadership skills to motivate and guide the quality control team and other departments to ensure quality compliance within the company.
Effective communication with cross-functional teams, regulatory bodies, and both internal and external stakeholders.
All employees are expected to provide customer service, communicate in an effective manner both verbally and in writing, display professionalism and integrity, as well as work efficiently, effectively, and accurately. Employees should take the initiative, solve problems, display good judgment, and take ownership for delivering a high-quality product or service.
Essential Job Functions:
Lead and manage the Quality Control department, including incoming inspection, in-process inspection, final product inspection, and testing.
Ensure timely and accurate execution of quality control activities to support production schedules and product release timelines.
Develop, implement, and maintain QC procedures, specifications, and sampling plans in accordance with regulatory and internal quality requirements.
Lead investigations of nonconformances (NCRs), deviations, and out-of-specification (OOS) results; collaborate with cross-functional teams on root cause analysis and corrective actions.
Monitor QC metrics and trends; report findings to senior management and recommend improvements.
Provide leadership, training, and development to QC staff to maintain a high-performing team.
Coordinate with manufacturing, engineering, and quality assurance to support continuous improvement and resolve quality issues.
Education and Experience:
Bachelor’s or master’s degree in engineering or a related field.
Minimum of 5 years’ experience in quality management in a medical device manufacturing setting.
Minimum of 5 years’ experience managing a team.
In-depth knowledge of medical device regulations, including FDA QSR and ISO 13485:2016.
Experience with Class III medical device development and manufacturing is strongly preferred.
Experience conducting internal and supplier audits.
Working knowledge of statistical process control, design control, and other quality tools.
Excellent problem-solving and analytical skills.
Strong communication and team collaboration skills
Ability to work in a fast-paced and dynamic environment.
Physical Demands:
Ability to sit or stand for long periods of time.
Ability to lift, bend or move up to 25 pounds.
Ability to adjust work schedule to meet deadlines and deliverables.
Compensation:
$109,000 to $150,000 Annually, depending upon experience
Paid Vacation
Paid Holidays
Paid Sick Leave
Partial Payment by Company of Group Health, Dental, and Vision Insurance
401(k) with limited company matching
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Title: Quality Engineer II
Company: Pursuit Aerospace
Location: Whitesboro, NY
