Quality Engineer

The Interventional Urology Operations Quality Engineer is responsible for supporting and maintaining quality compliance and will recommend and implement process improvements within US Operations. In all actions, they will demonstrate a primary commitment to patient safety and product quality.

Major Areas of Accountability

• Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues.
• Recommend and implement quality improvements and processes to ensure regulatory compliance and promote continuous improvement.
• Conduct and document root cause investigations of non-conforming processes and products.
• Facilitate Material Review Board meetings.
• Participate in or lead Corrective and Preventive Actions as appropriate.
• Review sampling techniques/methods/rationale and test methods to ensure appropriateness.
• Review quality content in change control for products and processes.
• Review and author validation documents and validate processes.
• Initiate Change Requests to update documentation and processes.
• Perform data analysis; write summary reports and other technical memoranda.
• Coordinate and support calibration activities - including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed.
• Maintain applicable QMS instructions.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other duties as assigned.

Basic Qualifications

• Bachelor's degree in a relevant science or engineering discipline.
• 2+ years related experience in medical device manufacturing.
• ASQ Certified Quality Engineer preferred

Competencies

• Experience with process validation, change control systems, sample size determination, FMEA, and Gage R&R.
• Knowledge of various statistical techniques and Analytical problem-solving skills.
• Excellent data analysis skills and proficiency using statistical tools (e.g. Minitab).
• Ability to successfully work within a team-based environment.
• Effective verbal and written communication skills.
• Ability to effectively manage multiple projects and priorities.
• Effective computer skills including knowledge of Microsoft Office (Word, Excel, PowerPoint).

• Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
• Ability to apply standard techniques, procedures, and criteria to perform assigned tasks.
• Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the operations quality function.
• Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
• Preferred experience with Medical Device Systems with Software and Electrical Components
• Experience performing internal audits.
• Personifies and fosters the Coloplast Mission, Vision and Values.