Quality Engineer

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.
• 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.
• Cook up calibration activities - including ensuring equipment is appropriately calibrated and out-of-calibration issues are properly addressed.

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

Required Knowledge, Skills and Abilities

• 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.

At Coloplast

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans, wellness programs, and mental health resources.
• Financial Security: Competitive 401(k) plan with company match, financial planning services, and corporate discount programs.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options.
• Professional Development: Training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs, bonuses, awards, and special events.
• Sustainability Strategy: Details on how Coloplast runs its company sustainably.
• Competitive Compensation: Compensation range for this position is $88,372 - $132,558.

Pursuing an Ambitious Growth Agenda

• Develops and markets products and services that make life easier for people with intimate healthcare needs.
• Employment: About 16,000 people globally, products available in more than 143 countries.
• Commitment: To a policy of Equal Employment Opportunity (EEO).

Equal Employment 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.