Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Danvers, Massachusetts, United States of America
Job Description:Location: Danvers, Massachusetts, US, 01923
Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, Abiomed's 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
Patients First | Innovation | Winning Culture | Heart RecoveryThe Post Market Complaint Specialist II is responsible for reviewing clinical and product complaints to assess for reportability in compliance with global medical device regulations. The candidate must have experience in medical device and post-market regulations with a solid understanding of complaint handling processes and adverse event follow-up.
Principle Duties and Responsibilities:- Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
- Completes assessments of product complaints to determine reportability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments.
- Review all assigned clinical and product complaints for adverse events
- Interface with field reps. and clinical staff to acknowledge, document and obtain detailed information regarding adverse events and incidents received by the company
- Apply knowledge of medical device regulatory requirements to support the reporting decision process and identify reportable events as they are received
- Perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary.
- Complete Reportability Assessments in a timely manner in adherence with Abiomed's policies and procedures
- Identify possible trends related to complaints and present information or concerns to management using available programs and applications (e.g. PowerPoint, Excel, graphs, charts)
- Escalate complex complaint issues per department policies and guidelines.
- Work closely with engineering investigation teams to ensure the timely closure of technical investigations
- Interact with cross-functional teams to obtain information pertinent to the complaint investigation
- Write customer letters
Job Requirements: - Minimum 3+ years of work experience processing complaints within the device and/or pharmaceutical/life-sciences industry
- Bachelor's degree: Medical device experience preferred
- Demonstrated knowledge of global medical device and/or pharmacovigilance regulations
- Working knowledge/experience with domestic and international regulatory reporting requirements for medical devices (i.e. 21CFR 803, CMDR, Meddev 2.12, etc.) (experience with PMDA highly preferred)
- Excellent written, verbal & interpersonal communication skills
- Proficient in the use of Microsoft Office programs, specifically Excel, PowerPoint, Word
- Approachable with a positive attitude
- Critical thinker
- Exceptional attention to detail in documenting events, composing clinical narratives, and editing quality documents
- Demonstrated ability to manage multiple competing priorities and meet deadlines
- Ability to work independently and as a team player
- Experience using a global complaint handling database or quality management system e.g. Trackwise, Salesforce
- Possess strong complaint handling experience (i.e. 21CFR 820.198)
Applicants must provide proof that they are fully vaccinated with an FDA approved or authorized vaccine for COVID-19 or have a valid medical/religious exemption.
Required Skills:Preferred Skills:Audit Management, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment
The anticipated base pay range for this position is :$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
