Senior 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.
• C 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 Controls to update documentation and processes.
• Perform data analysis; write summary reports and other technical memoranda.
• Support calibration activities - including ensuring equipment is appropriately calibrated and out-of-calibration issues are properly addressed.
• Maintain applicable QMS instructions.
• Support and participate in Internal and External Audits

Basic Qualifications

• Bachelor’s degree in a relevant science or engineering discipline.
• 5+ years related experience and/or training

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.

Benefits

The compensation range for this position is $105,868 - $158,802. 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.

Pursuing an ambitious growth agenda, 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.

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.