Hologic Post Market Surveillance Engineer in Danbury, Connecticut
Post Market Surveillance Engineer (Job Number: 170814)
PURPOSE AND SCOPE:
Responsible for receiving, reviewing, and processing product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling incoming complaints. Partners with Product Support / Quality Engineering or other investigators on product investigations and trends.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Developing professional expertise, applies company policies and procedures to resolve a variety of issues, including fulfillment, assay and instrument complaints.
Can perform all the essential duties of Post Market Surveillance Specialists.
Responsible for escalated complaints. Can place material on quality hold, after approval by QA Management.
Facilitators on moderate to complex investigations.
Conducts timely and insightful response to investigations.
Performs department metrics and works with others to ensure department goal are met.
Prepares agendas, facilitates cross functional meetings and creates meeting minutes with supervision.
Engage owners on determination of effective CAPA.
Work with TS or Field Service to ensure appropriate required information is documented in complaint.
· Works on problems of moderate to major in scope where analysis of situation or data requires a review of a variety of factors.
Leads cross functional projects with supervision
Works with other PMSS and PMSE to ensure consistency in documenting complaints.
Ensures that complaints are assessed from MDR within 3 days of receipt.
Assist in external & internal audits.
Exercises judgment within defined procedures and practices to determine appropriate action.
Works with R&D to determine specific product and incident complaint codes.
Work on transfer of information for new products to the rest of the PMS team.
Participates on Post Launch Surveillance teams (PLST).
Reviews other customer communication (response letters, acknowledgement letters) as appropriate.
Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
Builds productive working and team relationships.
Acts as mentor to other Post Market Specialists; assists in new employee training.
Creates or update QMS documents,
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned.
Other duties as assigned.
Bachelor’s Degree required, preferably in a healthcare related field.
EXPERIENCE AND REQUIRED SKILLS:
· Minimum 2 - 5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations understanding of drug/device safety requirements are required; with an Advanced Degree no prior experience may be considered.
· Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
· Prior experience processing medical device or drug complaints strongly preferred.
· Strong interpersonal skills.
· Knowledge based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel.
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor
Primary Location: United States-Connecticut-Danbury
Organization: Regulatory and Quality Leadership
Shift: Day Job
Job Posting: Aug 8, 2017, 2:13:25 PM