Sr. Quality Engineer

OSYPKA MEDTEC INC•Longmont, CO

About The Position

The Sr. Quality Engineer is responsible for ensuring the quality and compliance of our products and processes in accordance with ISO and FDA regulations within the medical device manufacturing process for our Class II and Class III medical devices. This includes leading and conducting quality investigations, developing and implementing quality systems and procedures, design control remediation, process validations, and providing guidance and support to other members of the quality team. 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: Quality Management Systems Regulatory Compliance and Auditing Risk Management Design and Change Control Process Validations, test method validations Supplier Quality Management Statistical Analysis Problem-Solving, Investigations, and Root Cause Analysis Continuous Improvement 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 engineering, science, or a related field
Minimum of 4 years of experience in a quality engineering role in a medical device or pharmaceutical company.
Strong knowledge of quality control principles, methodologies, and tools used in the medical device industry.
Solid understanding of ISO 13485:2016 and FDA part 21 CFR 820 regulations is required.
Experience with quality investigations and CAPA management.
Experience with Lean Manufacturing principles
Understanding of Design Control and Change Control processes.
Solid understanding of statistics and process validation, test method validation principles.
Excellent communication and problem-solving skills.
Strong computer skills, including proficiency in using MS Office.
Detail oriented with strong organizational and analytical skills.
Ability to work independently and in a team environment.

Responsibilities

Lead and facilitate technical meetings with clients and customers on quality-related topics, including design controls, risk management, CAPAs, and regulatory compliance, serving as a primary quality representative.
Lead and conduct design related quality investigations, root cause analyses, and corrective and preventive actions (CAPAs) ensuring effective containment, corrective actions, and risk mitigation across the product lifecycle.
Develop and implement design quality systems and procedures to ensure compliance with FDA (21 CFR 820.30), ISO 13485, and ISO 14971 requirements.
Participate in cross-functional teams to ensure quality is built into all stages of the product development and manufacturing process.
Lead and participate in design control and change control activities for development and manufacturing projects including review and update of design history files.
Partner with cross functional teams like R&D, Manufacturing, and Regulatory to ensure quality and compliance are embedded throughout design, development, and design transfer activities.
Participate in cross-functional teams to develop manufacturing work instructions for new products.
Excellent understanding of process validation activities (IQ, OQ, PQ) and test method development and validation.
Support design verification and validation (V&V) activities, including protocol review, test method validation, acceptance criteria definition, and traceability to design inputs.
Develop and implement operator training and qualification assessments in partnership with subject matter experts and the training & development specialist.
Interface with FDA and ISO auditors during inspections and provide necessary documentation and support.
Evaluate suppliers to ensure their products and services meet quality standards.
Provide guidance and mentoring to other members of the quality team.
Identify areas for continuous improvement and drive initiatives to enhance quality processes and systems.
Stay up to date with changes in ISO and FDA regulations and industry best practices related to quality.
Additional work as defined by executive leadership.