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About the Role

The Interventional Urology Operations Quality Engineer supports and maintains quality compliance and recommends and implements process improvements within US Operations, with a primary commitment to patient safety and product quality.

Responsibilities

• 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.
• 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.
• Conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Perform other duties as assigned.

Requirements

• 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.
• Ability to apply standard techniques, procedures, and criteria to perform assigned tasks.
• Preferred experience with Medical Device Systems with Software and Electrical Components.

Skills

• FDA regulations (21 CFR Part 820)
• ISO standards (13485, 14971)
• Process validation
• Change control systems
• Sample size determination
• FMEA
• Gage R&R
• Continuous improvement
• Lean six-sigma
• Internal audits

Experience Level

• 2+ years related experience in medical device manufacturing

Education Level

• Bachelor’s degree in a relevant science or engineering discipline
• ASQ Certified Quality Engineer preferred

Salary/Compensations

• $88,372 - $132,558

Benefits

• Comprehensive medical, dental, and vision insurance plans
• Company sponsored wellness programs and mental health resources
• Paid leave of absence for qualifying events
• Generous paid parental leave for both birthing and non-birthing parents
• Competitive 401(k) plan with company match that vest immediately
• Financial planning services
• Corporate discount programs for goods and services
• Generous paid time off
• Flexible work hours
• Flexible work arrangement options may be available
• Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
• Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
• Supportive work environment where everyone feels valued, and has a sense of belonging
• 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

About the Company

• Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs.
• Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies.
• We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.
• Visit us on Coloplast.com.
• Watch the film.
• Follow us on LinkedIn.
• 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.

Equal Opportunity

• 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.