Quality Specialist

OSYPKA MEDTEC INC•Longmont, CO

1d•Onsite

About The Position

The quality specialist will play a critical role in ensuring compliance with ISO and FDA regulations in our Class II/Class III medical device development and manufacturing processes. This individual will work closely with cross-functional teams to develop and implement quality control processes, maintain quality management systems, and support continuous improvement initiatives. 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 ISO 13485:2016 and FDA regulations Quality Management Systems and Risk Management Quality Metrics and Reporting Document Control, Change Control, and Corrective and Preventive Actions Training and Continuous Improvement Problem-solving, Attention to Detail, and Time Management 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.

Requirements

Bachelor's degree in a related field, such as engineering or life sciences preferred.
Minimum of 1-3 years of experience in quality assurance in a regulated industry, preferably medical device or pharmaceutical.
Experience with quality management systems, such as Document Control, Non-Conforming Materials, and Corrective and Preventive Actions.
Auditing experience and knowledge of quality auditing principles.
Excellent communication and interpersonal skills.
Attention to detail and strong analytical skills.
Proficiency with Microsoft Office and general office equipment.
Ability to work independently and collaboratively in a team setting.

Nice To Haves

Familiarity with risk management and design control processes, preferred.

Responsibilities

Develop and implement quality control processes and procedures to ensure compliance with ISO and FDA regulations.
Conduct and/or participate in internal audits to assess compliance with quality management system requirements.
Participate in and support regulatory audits to maintain certifications.
Collaborate with cross-functional teams to identify and address quality issues, non-conformances, and process improvements.
Maintain and update quality management system documentation, including policies, procedures, and work instructions.
Provide training to employees on quality management system requirements and processes; assist in developing training plans and documentation of completed training.
Evaluate vendors and suppliers to ensure they meet quality standards and regulatory requirements.
Monitor and analyze quality data to identify trends and opportunities for improvement.
Support product development and validation activities, including risk management and design control.
Prepare and submit required reports to regulatory agencies, such as FDA or Notified Bodies.
Participate in the development and review of quality agreements with clients and/or suppliers.
Stay up-to-date on changes in regulatory requirements and industry best practices related to quality and compliance.