Post Market Surveillance Intern (Complaint Lab) Job Locations US-MA-Billerica | US-MA-Billerica Posted Date 3 days ago (6/5/2018 2:28 PM) Category Quality Assurance / Quality Engineering Position Summary Supporting Post Market Investigation Lab through material handling, device receipt, data entry, data analysis, reporting, documentation review, coordination of complaint and lot qualification data, device history reviews including review and closure of certain categories of complaints. It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks. Assignments will provide basic knowledge of complaint handling and post market investigation process of FDA approved medical devices. Candidates in engineering fields and previous experience in medical device field may be introduced to performing device investigations. Responsibilities Perform moderately complex tasks to ensure compliance with quality standards. Work with quality assurance engineers and other team members to ensure effective inspection and testing procedures are implemented and maintained. Generate, review and maintain Quality records in support of the Quality System, e.g., training, internal audits, NCR, and CAPA. Perform product testing and failure analysis. Review and track Lot Acceptance records and DHRs, create trend charts. Perform data logging of quality data and trend results. Gather data where needed. This involves consistent follow up and expediting actions. Trouble shoot failure modes. Perform deep dive investigations to develop hypothesis for failure Perform other duties as assigned. Education and Experience Minimum Requirement(s): Students in Biomedical, Biomechanical, Mechanical, Electrical engineering fields. Preferred Skills and Competencies: Electrical and mechanical background strongly preferred. Computer proficiency in MS office (specifically Excel); experience creating and analyzing charts and Pareto charts a plus. Effective verbal and excellent technical writing skills Ability to communicate and work effectively within and across the organization. Ability to organize and follow through with tasks with minimal supervision. Excels at generating and maintaining organized and accurate records. Physical Requirements (if applicable): Occasional (<10% of work time) lifting up to 20 lbs. Rare (<1% of work time) push/pull up to 50 lbs.