| Major Areas of Accountability |
- Supervisor
- Responsible for the supervision, scheduling, training, and development of direct reports.
- Responsible for Performance and Development Reviews for staff.
- Coordinate and adapt as necessary to meet the needs of Operations, respond to changes/emerging issues, and maintain production.
- Partner with other departments for project support.
- Individual
- Execute quality control and calibration activities as needed to maintain production.
- Responsible for root cause analysis and implementation of corrective actions related to quality control and calibration Nonconformances and CAPAs.
- Assist or execute DHR reviews in support of complaints, nonconformances, etc.
- Continuously drive improvements, utilizing Lean principles.
- Support internal or external audits.
- Quality Control
- Gather, analyze, communicate, and ensure the integrity of generated data.
- Create, review, and optimize sampling procedures, policies, and methods.
- Identify and drive improvements to production methods, equipment performance, and design specifications.
- Calibration
- Responsible for the calibration program – including the procedures, execution, and oversight.
- Ensures equipment is calibrated on time and appropriately; coordinates with external calibration personnel.
- Identify, escalate, and resolve calibration issues.
- General
- Conform with Coloplast Code of Conduct and all local Compliance Standards.
- Conform with Coloplast Q/EHS Policy.
- Other duties as assigned.
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| Essential Qualifications |
- Minimum 8 years related experience and/or related training – including supervisory experience.
- Experience demonstrates expertise in interrupting regulations/standards, FDA, ISO, etc.
- Experience working with inventory management systems (ERP/MRP) and medical device manufacturing.
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| Required Knowledge, Skills and Abilities |
- Ability to define objectives and provide clear direction to team members.
- Excellent written & oral communication skills.
- Ability to organize efficiently and effectively – managing multiple projects and changing priorities.
- Ability to convey a positive and professional image to internal and external customers.
- Ability to exercise logical and sound judgment, and collaborate with cross functional teams.
- Methodical problem solving skills with practical application.
- Must be flexible with work schedule.
- Ability to work independently as well as in a team environment.
- Ability to complete project deliverables on time and in compliance with regulatory requirements.
- Personifies and fosters the Coloplast Mission, Vision and Values.
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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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.
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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.
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Nearest Major Market: Minneapolis
