Sr. Quality Engineer
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, 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
· 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.
Essential Job Functions:
• Lead and conduct quality investigations, root cause analyses, and corrective and preventive actions (CAPAs) to address quality issues and ensure timely resolution.
• Develop and implement quality systems and procedures to ensure compliance with ISO and FDA regulations.
• 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.
• Work with operations on lean initiative projects to improve quality and manufacturing efficiencies.
• Participate in cross-functional teams to develop manufacturing work instructions for new and existing products.
• Develop and implement operator training and qualification assessments.
• Conduct internal audits to assess compliance with quality systems and procedures.
• 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.
• Develop and maintain quality metrics to track and monitor quality performance.
• 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.
Education and Experience:
• Bachelor’s degree in engineering, science, or a related field
• Minimum of 5 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 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.
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: