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Post Market Surveillance Engineer

Location: 

Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States

Post Market Surveillance Engineer 

Coloplast has an exciting opportunity for a Post Market Surveillance Engineer to join our growing team!

 

This position is essential to the compliance of the company with FDA and international regulatory authorities.  This position 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. This position will also contribute to product review, root cause investigations and analysis of complaint data and deliver appropriate presentations.
 

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, physician’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 physician’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.
  • Develops and implements methods and procedures for effective trending and communication of complaints and associated metrics.
  • 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.
  • 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
  • Maintains the Implant Registry Database
  • Provides feedback on Voice Of the Customer (VOC) to R&D
  • Assist with assigned complaint handling CAPA project activities, as needed
  • Additional duties as assigned

 

Basic Qualifications

  • BA/BS in a life sciences field or 4-year engineering technical degree required
  • 3-5 years’ experience working in a complaint handling/Post Market/MDR capacity is desired
  • Experience with 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 to advanced level expertise using MS Office applications (Word, Excel, PowerPoint)
  • Ability to work individually and as a team leader
  • Ability to multi-task
  • Basic to intermediate statistical knowledge

 

Environmental, Health and Safety Responsibilities

This position will support Coloplast Manufacturing EHS Goals and Objectives:

  • Enforce all company Environment, Health, and Safety policies
  • Ensure employees are properly trained
  • Provide detailed instructions for job performance and explain hazards and safety precautions in assigning employees to a task
  • Plan the work to be certain that employees, material, and equipment are available to perform task safely.
  • Promptly report all incidents in area(s) of responsibility
  • Conduct effective accident investigations immediately after they occur and implement effective corrective actions to ensure that the accident does not reoccur
  • Ensure injured employees receive proper first aid and/or medical treatment
  • Follow-up on all safety related deficiencies to ensure corrective action has been completed
  • Actively support and promote Environment, Health, and Safety activities within the organization

 

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.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

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

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