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This position is responsible for ensuring compliance to Quality Systems training, change control and supporting other quality compliance activities and projects for the Interventional Urology (IU) ID site. This position directly contributes to the efficiency of the Quality Assurance team by building and maintaining strong cross-functional relationships and ensuring conformance to applicable MDR, QS, and other quality requirements.
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Major Areas of Accountability:
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- Quality Systems Training / Document Control / Compliance
- Facilitate the timely change, approval and release of product documentation and data (PLM, ERP)
- Ensure all documents follow appropriate naming and numbering procedures
- Support development of new product documentation, as required
- Administer the system for archiving applicable Quality records (both on-site and off-site storage) in accordance with defined requirements and procedures
- Provide high level customer service and support to specific cross-functional areas
- Assist in monitoring process effectiveness including the impact of changes and take the initiative to recommend process improvements and ensure procedures are in place to classify and maintain appropriate records
- Provide user training to change control systems, as directed
- Support use of the established learning management system (LMS) used to manage direct and indirect labor training for IU ID, including surge support for IU SD
- Maintain accurate training records, in accordance with applicable regulations and requirements
- Support IU ID production with direct labor training, as directed
- Conduct general Quality System training to new employees, as applicable
- Coordinate and deliver annual Quality System training (i.e., GMP, GDP), as required
- Monitor training status for the IU ID site – identifying, escalating, and resolving identified risks
- Report on performance of training process to site level management, as applicable
- Support internal and external audits, as requested
- General
- Support production to maintain commercial supply and quickly respond to emerging issues; enable efficient review and update of new product and component documentation
- 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 and as the business unit evolves
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Basic Qualifications:
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- Bachelor's degree in a technical field, or 3+ years equivalent experience with high school diploma
- Experience in a medical device development or manufacturing environment
- Experience with Class II and Class III implantable medical devices
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Required Knowledge, Skills and Abilities:
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- Experience administering within a Learning Management System (LMS)
- Experience administering within a change management system (PLM)
- Knowledge of the principles and best practices of quality systems training, change management, and quality compliance
- Knowledge of FDA, ISO 13485, EU MDR, and related quality system regulations
- Proficient in oral and written communication skills
- Customer service focused with the ability to support a variety of levels cross-functionally
- Results oriented with the ability to be accountable to the achievement of both individual and team goals
At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:
- 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 vest 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 may be available.
- 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 and inclusive work environment where everyone feels valued, and diversity is celebrated. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Employee Resource Groups that support Women, Minorities, Veterans and LGBTQ+ Community. 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 $58,707 - $88,060. 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.
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