Job Description

Job Function Summary
Supports Value Stream by performing inspections of incoming, in-process and finished goods. Responsible for preparation and release of Surgical sterile loads. Ensure documentation and DHRs meet FDA QMSR and ISO 13485 requirements.

Major Areas of Accountability

• Perform visual and dimensional inspections of materials including incoming, in-process assemblies and finished goods
• Perform product and incoming tests, using equipment including calipers, micrometers, microscopes, visual measurement systems, etc.
• Assist calibration system; including ensuring equipment is appropriately calibrated and out of calibration issues are properly addressed as a calibration coordinator
• Assist with review and ensure drawings and procedures are up to date
• Verify production records for completeness and accuracy and records required for inspections, audits, and corrective actions (including device history records and non-conformance reports)
• Prepare and release sterile product; pull pyrogen and bioburden samples as required
• Perform release of raw/incoming materials and finished goods in ERP system
• Segregate and disposition quarantined and rejected materials (reworks/sorts) and completes necessary documentation; Place material on hold/quarantine in ERP when appropriate
• Re-inspect quarantined material and process rejected materials (reworks/sorts) and complete necessary documentation
• Identify any functional problems and work with engineers and operators to resolve production or quality issues
• Assist production and purchasing with resolution of quality issues regarding incoming or in-process materials
• Maintain and appropriately file records of testing and sterilization completed
• Responsible for incoming inspection of tissue bank product
• Create and provide CoC’s for finished goods as requested by sales subsidiaries

• Conform with Coloplast Q/EHS Policy

• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other duties as assigned

Basic Qualifications

• Associate’s Degree or equivalent related experience required
• 3+ years of quality inspection experience, preferably in a medical device environment

Ability to lift 20 pounds

Required Knowledge, Skills and Abilities

• Knowledge in areas of chemical, physical, and dimensional inspection techniques, equipment, and documentation
• Knowledge of QSR/ISO 13485 requirements preferred
• Ability to read and accurately follow written instructions/documents
• Ability to read and understand drawings, bills of materials, specifications, inspection procedures, and certifications
• Verbal and written communication skills for multi-level company interaction
• Ability to apply mathematical operations to perform audits and incoming inspections
• Working knowledge of Microsoft Office, Trackwise and Lotus Notes systems
• Organized and detail oriented
• Lean and continuous improvement experience preferred
• Good time management skills and the ability to multi-task
• Ability to work under the direction of the senior Quality Inspector Employees, work towards working independently, and be self-directed

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.
• 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 work environment where everyone feels valued, and has a sense of belonging. Participate in 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.
• Competitive Compensation: The hourly rate for this position is $25 - $30. Hired candidates may be eligible for bonuses and/or incentives. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location.

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.

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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.

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