Post Market Surveillance Analyst

4 weeks ago

Port Washington, United States Drive Medical Full time
Job DescriptionJob Description

Who is Drive DeVilbiss…

Drive DeVilbiss has become a leading manufacturer of medical products with a strong and consistent track record of growth achieved both organically and through acquisitions. We are proud of our high-quality, diverse product portfolio, channel footprint and global operating scale. Our products are sold into the homecare, long-term care, retail and e-commerce channels in more than 80 countries around the world.

“Leading the World with Innovative Healthcare Solutions that Enhance Lives”

Summary (Major Purpose of the Role):

In compliance with applicable regulations, the Post Market Surveillance Analyst is responsible for supporting the complaint handling system through the timely assessment, processing, distribution of information, and communication of alleged product quality defects for all medical devices within the scope of Drive DeVilbiss Healthcare.

Main Activities/Responsibilities:

  • Manage all received complaints to immediately identify any potentially expedited quality/compliance issues.
  • Responsible for recording and entering quality complaint information received
  • Determine when a complaint should be investigated or recorded for trending purposes only.
  • Able to effectively communicate with customers and provide feedback to customers on complaints.
  • When required complaint sample should be retrieved for evaluation.
  • Complete daily workload while maintaining consistent, quality work and compliance with established procedure and timelines.
  • Contact reporter, as necessary, to gather additional complaint information to ensure we are adequately evaluating the alleged complaint

Competencies:

  • Strong written and oral communication skills are required
  • Good problem-solving skills
  • Proficient computer skills are required, i.e. Microsoft Office Suite, including Word, Excel, Outlook and SharePoint.
  • Ability to work within a team and as an individual contributor in a fast-paced
  • Effectively multitasks, prioritizes, and meets timelines
  • Strong organizational and follow-up skills, as well as attention to detail
  • Ability to maintain regular and predictable attendance

Reporting Relationships and Supervision:

  • This position will directly report to the Post Market Surveillance Supervisor

Education and Experience:

  • BS degree in Life Sciences or ASQ or other related certifications preferred.
  • Versed in the QSR, ISO 13485 and related quality Standards.
  • Strong working knowledge of complaints management systems
  • Strong Cross departmental communication skills, someone who enjoys working cross functionally, helping to identify important department interfaces, and streamlining processes in a growing and rapidly changing environment.
  • Strong understanding of Quality processes related to incidents and complaints and how that interface with FDA eMDR reporting requirements.
  • Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative, enthusiasm, commitment, and motivation.
  • 1-2 years of experience in the medical field industry.

Why Apply to Drive DeVilbiss…

Competitive Benefits, Paid Time Off, 401(k) Savings Plan.

Pursuant to New York law, Drive DeVilbiss Healthcare provides a salary range in job advertisements. The salary range for this role is from $52,400.00 to 54,000.00 per year. Actual salaries may vary depending on factors such as the applicant’s experience, specialization, education, as well as the company’s requirements. The provided salary range does not include bonuses, incentives, differential pay, or other forms of compensation or benefits which may be offered to the applicant, if eligible according to the company’s policies.

“Drive DeVilbiss is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants for employment. Drive DeVilbiss strictly prohibits and does not tolerate discrimination against employees, applicants, or any other covered person because of race, color, religion, gender, sexual orientation, gender identity, pregnancy and/or parental status, national origin, age, disability status, protected veteran status, genetic information (including family medical history), or any other characteristic protected by federal, state, or local law. Drive DeVilbiss complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.”

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