Career Opportunities: Post Market Surveillance Quality Engineer (45813) Req ID 45813 - Posted 02/01/2019 - United States - Minnesota, Minneapolis - Quality Assurance î??  Job Description Print Preview  Post Market Surveillance Quality Engineer Coloplast has an opportunity available for a Post Market Surveillance Quality Engineer to join our growing team at our Minneapolis headquarters.  This position is essential to the compliance of the company with FDA and international regulatory authorities. You will be responsible for receiving, evaluating, and processing customer/product complaints for Coloplast products. This is a very customer-focused position and will have daily interactions with internal and external customers.  Major Areas of Accountability * Receives and processes customer complaints in accordance with FDA, ISO 13485 and other regulatory requirements * Ensures complaints from written, electronic, and oral communications are entered into the complaint handling database in accordance with procedure * Makes initial assessment as to whether a complaint is reportable by applying knowledge of medical device regulatory requirements * Contacts hospital, physicianâ??s office or sales representative to request product return and additional information to adequately investigate a customer complaint * Conducts product complaint investigations including visual inspection and product testing to confirm the reported issue(s). May coordinate investigation with appropriate departments (R&D, Value Stream, or Production) and document results * Ensures root cause investigation is conducted and documented on returned product * Coordinates with outside suppliers (CM products) the evaluation response for returned product and documents these findings in the complaint handling database * Takes initiative and action to respond, resolve, and follow up on all product complaints in a timely manner * Writes correspondence to the physicianâ??s office regarding results and conclusions of the complaint investigation * Alerts the Quality Systems management and others of unusual or high-risk events requiring review by Legal or Regulatory Affairs * Ensures complaint failure types are included in the complaint handling database and within the current risk management documentation * Facilitates monthly Product Review meetings and performs analysis of complaint data as an input to these meetings * Collaborates with Regulatory Affairs regarding adverse event reporting and generating complaint data reports * May provide guidance and direction to Product Evaluation team members and determines prioritization of daily activities * May provide complaint training to sales and other employees  Essential Areas of Accountability * Coordinates with other Coloplast departments to ensure accurate and timely communication of customer complaints to Product Evaluation including Sales, Marketing, R&D, Clinical, Regulatory Affairs and Legal * Responsible for maintaining complaint files within a secured environment * Maintains and retains complaint records in accordance with the US record retention policy * Conforms with Coloplast Q/EHS Policy * (http://www.coloplast.com/About/responsibility/Documents/QEHS%20policy.pdf) * Additional duties as assigned  Essential Qualifications * BA/BS in a life sciences field or 4 year engineering technical degree * 3-5 years experience working in a complaint handling/Post Market/MDR capacity is desired * Experience with TrackWise or other similar complaint management database required * Degree in a technical or life sciences discipline is desired * Experience in a medical device development or manufacturing environment is desired * Experience with Class II and Class III implantable medical devices is desired  Required Knowledge, Skills and Abilities * Excellent verbal and written English communication skills * Excellent analytical skills * Knowledge of 21 CFR 820, 21 CFR 803, ISO 13485 and ISO 14971 * Intermediate level expertise using MS Office applications (Word, Excel, PowerPoint) * Ability to work individually and as a team leader * Ability to multi-task * Basic statistical knowledge  The job information contained herein will apply to the candidate successful in being hired for the position. If interested, please apply today!  Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 10,000 people and with products available in more than 100 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 â?? we explore, learn and look for new ways of doing things. Curiosity works here.  Visit us on Coloplast.com. Follow us on LinkedIn. Like us on Facebook.  EOE M/W/Vets/Disabled Â