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.

• 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.
• Work with new product development teams to transfer new products into manufacturing.
• Conduct and document root cause investigations of non-conforming processes and products.
• 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 calibration issues are properly addressed.
• Maintain applicable QMS instructions.
• Other duties as assigned.

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

• Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
• Experience with process validation, change control systems, sample size determination, FMEA, and Gage R&R.
• Ability to effectively manage multiple projects and priorities.
• 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.
• Experience in performing internal audits.
• Personifies and fosters the Coloplast Mission, Vision and Values.
• Preferred experience with Medical Device Systems with Software and Electrical Components.

• Health and Wellness
  :
  Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus access to company-sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
• Financial Security
  : A competitive 401(k) plan with company match that vests immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance
  :
  Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life.
• Professional Development
  :
  Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards
  :
  Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture
  : A supportive work environment where everyone feels valued, with team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation
  :
  The compensation range for this position is $88,372 - $132,558. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.