[Hiring] Exp Anlst Cust Qual @Johnson & Johnson Innovative Medicine

Role Description

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.

• 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 reportability 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.
• Escalate complex complaint issues per department policies and guidelines.
• May prepare and/or review 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.

Qualifications

• Bachelor degree or equivalent combination of education and experience with a minimum of 2+ years experience with data management, record keeping, and troubleshooting in Medical Device field, or other transferable 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.
• 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. ECM, Salesforce.
• Possess strong complaint handling experience (i.e. 21CFR 820.198).

Requirements

• 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

Benefits

• Base pay range: $79,000.00 - $127,650.00
• Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Eligible to participate in the Company’s long-term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time - 40 hours per calendar year; for employees who reside in Colorado – 48 hours; for employees who reside in Washington – 56 hours.
• 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.