Exp Anlst Cust Qual

Johnson & Johnson Innovative Medicine•Danvers, MA

1d•$79,000 - $127,650•Onsite

About The Position

Established and productive individual contributor, who works under moderate supervision. Supports the execution of tasks related to fulfilling the quality and regulatory requirements and established standards and customer needs for the organization's products, processes, and services. Implements strategy and vision of continuous improvement and feedback through assessments and reporting. Develops close partnership with all marketing companies functions and external business partner to identify risks and improvement opportunities and enhance the customer experience. Documents business critical issues in Customer/Commercial Quality and tracks regulatory changes. Applies in-depth knowledge of Customer/Commercial Quality and surfaces policies that may impact organizational objectives. Conducts routine collection and dissemination of feedback to ensure continuous improvement of the quality management system. Completes processes to ensure internal organization's alignment with overall quality priorities. Implements formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems. Analyzes complex research and data related to regulatory changes, external trends, and strategy. Contributes to customer handling complaint process, and establishes and maintains Quality System Elements. Coaches more junior colleagues in techniques, processes, and responsibilities. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. The 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.

Requirements

Bachelor degree or equivalent combination of education and experience with a minimum of 2+ year’s experience with data management, record keeping, and trouble shooting in Medical Device field, or other transferrable experience related to organization, technical aptitude, and data management.
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
Approachability 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. ECM, Salesforce
Possess strong complaint handling experience (i.e. 21CFR 820.198)

Nice To Haves

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

Responsibilities

Responsible for operational aspects of the team including, workflow, performance and compliance
Supervises individual contributors and conducts effective performance management
Coordinates processes and Assignment of daily work for the team
Assists in the review of the use of systems to ensure document standards are maintained
Assists with implementation of process changes and procedural updates
Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
Ensures close partnerships with upstream and downstream customers to identify risks and improvement opportunities.
Completes assessments of product complaints to determine report ability and coordinates complaint investigations between the quality assurance department, engineering, customer support and other departments.
Support investigations and review of potential adverse events.
Perform data entry and prepare reports/ graphs related to special projects, complaints and lot qualification as necessary.
Process feedback letters and communications with various reporting sites.
Support investigations and review of potential adverse events.
Escalate complex complaint issues per department policies and guidelines.
May prepare and/or reviews regulatory submissions and completes international vigilance reports of adverse events as required.
Evaluates and confirms information from a technical perspective to ensure appropriate analysis, investigation, and that the root cause is documented prior to complaint closure.
Partners with appropriate functional departments to achieve effective corrective action on severe and/or recurring problems.

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program