Quality Specialist

Quality Specialist

This position will be a full-time benefited position which controls, designs and organizes the quality management system elements in an ISO 13485 / 21CFR Part 11 regulated environment producing Class II and Class III medical devices and products.

Organizational Competencies & Cultural Values:
The mission of every employee at Osypka Medtec is dedicated to serving, supporting, and improving the lives of our patients and customers by adding value through innovative quality medical devices and services.

This position supports the organizational principles which plans, promotes and embraces an attractive and high quality living and working environment by facilitating ethical decisions for a growing organization. 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:

• Work independently with minimal supervision and as part of a team.
• Perform basic to complex calculations, equations, and analysis of engineering data for equipment, processes or other types of requirements.
• Make decisions exercising critical technical judgement on more difficult and unusual projects.
• Prepare reports with minimal supervision for the engineer team, quality, customers or suppliers.
• Complete necessary training and have the ability to follow Quality Management System.
• Establish and maintain effective working relationships with fellow employees, customers and suppliers.
• Maintain regular and punctual attendance.

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 initiative, solve problems, display good judgment, and take ownership for delivering a high quality product or service.

Essential Job Functions:

• Responsible for investigating, analyzing, containing and correcting quality problems related to products, including but not limited to incoming inspections, quality inspections of work in process, or final inspections.
• Coordinate phases of quality control/assurance activities of new and existing projects to ensure product quality, schedules and time frames meet customer requirements with engineering and management, as well as with customers when required.
• Analyze and provide input regarding quality of raw materials, purchased parts, and other items required to manufacture.
• Analyze processes for improvements, failure modes, sustainability and capability.
• Coordinate requests for Change Orders, including preparing supporting documentation, communications, sample part review and scheduling for projects in engineering and quality.
• Complete paperwork for incoming inspections and conduct inspections of consumables, components, tools and other parts as required.
• Complete inventory of stock monthly for Osypka Medtec and customers, as well as end of year work in process.
• Ensure that any new inspection equipment for product/process is approved and maintained in the calibration system and that maintenance and cleaning are scheduled and completed.
• Maintain and help manage quality assurance documents including the procedures, quality manual, PFMEA and other documents. Conduct analysis review for Management Review Meetings and help with audits.

2022 March

• Maintain the supplier activities and implementation of them into the Quality Management System. Review trends and data on suppliers and discuss with the Quality manager any issues that need to be addressed.
• Initial, prepare, and present plans for quality improvements and train required team members.
• Complete miscellaneous reporting, administrative and other quality related functions, including change orders, tracking for projects and customer inquiries.
• Perform audits and implement new strategies to improve Quality System, flow of work, projects and inventory.
• Completes all documentation as required to maintain compliance with business practices and Quality

Management System.

• Capable of solving typical engineering problems at appropriate level for position through the use of analytical thinking to break down complex problems into manageable components.
• Prepares quality status reports by collecting, analyzing, and summarizing information and trends; recommending actions including costs for management.
• Maintains safe and clean working environment by enforcing procedures, rules, and regulations.
• Maintains product and company reputation by complying with federal and state regulations and industry requirements and standards.
• Contributes to team effort by accomplishing related tasks as needed. Will be required to perform other duties as required, directed or assigned.

Education and Experience:

• Degree in Engineering or Natural Sciences preferred, or three years’ experience in quality control environment.
• Certification in Quality field desired.
• Experience working with manufacturing based technology processes and principles required.
• Demonstrated Microsoft software; two years ISO 13485 and FDA experience required.
• Must have good verbal and written communication skills.

Physical Demands:

• Ability to sit or stand for long periods of time.
• Ability to lift, bend or move up to 40 pounds.
• Ability to travel by car, plane or train.

Compensation:

• $64,000 to $86,000 Depending on Qualifications
• Exempt, Full-Time
• Paid Vacation
• Paid Holidays
• Paid Sick Leave
• Partial Payment by Company of Group Health Insurance
• 401(k) with limited company matching
• No moving expenses will be provided

Job Type: Full-time

Pay: $64,000.00 - $86,000.00 per year

Benefits:

• 401(k)
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• ISO 13485: 2 years (Preferred)

Work Location: One location