Quality Inspector

Select how often (in days) to receive an alert: Supports Value Stream by performing inspections of incoming, in-process and finished goods for implantable medical devices. 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, mechanical and electrical, using equipment including calipers, micrometers, microscopes, visual measurement systems, etc. Responsible for inspection of electrical components including PCBA boards for visual, continuity, and functional features Assist with reviewing and ensuring drawings and procedures are current Responsible for inspection of electrical components including PCBA boards for visual, continuity, and functional features. Verify production records for completeness and accuracy and records required for inspections, audits, and corrective actions (including device history records (DHRs) and non-conformance reports (NC)) Prepare and release sterile products; pull pyrogen and bioburden samples as required Perform release of incoming materials and finished goods in ERP system Segregate and disposition quarantined materials (reworks/sorts) and complete necessary documentation; Place material on quarantine in ERP when appropriate Re-inspect quarantined material and process rejected materials and complete necessary documentation Effectively work with engineers and operators to investigate and resolve production or quality issues Assist production, quality, and purchasing with resolution of issues regarding incoming or in-process materials Assist with calibration activities - including ensuring equipment is appropriately calibrated and out-of-calibration issues are properly addressed Aid in maintaining and appropriate file records of testing and sterilization Create and provide CoC’s for finished goods as requested by sales subsidiaries 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 High School diploma or equivalent qualification required 5+ years of quality inspection experience, preferably in a medical device environment Ability to lift 20 pounds Required Knowledge, Skills and Abilities Knowledge of QMSR/ISO 13485 requirements preferred but not required Ability to read and accurately follow written instructions/documents 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 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 compensation range for this position is $46,960 - $70,441. 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. 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. Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark #J-18808-Ljbffr