What are the responsibilities and job description for the Quality Associate Post Market Surveillance position at OriGen Biomedical?
COMPANY
OriGen Biomedical is a global leader in cryopreservation and cell culture. We collaborate with top researchers, clinicians and business partners to enhance solutions, improve patient outcomes, and achieve customer satisfaction by providing safe and effective products that positively impact the quality of life.
POSITION SUMMARY
The Post Market Surveillance (PMS) Associate is responsible for managing post-market surveillance activities, including handling complaints, conducting investigations, and ensuring compliance with regulatory requirements. The role involves analyzing data, preparing reports, and supporting continuous improvement efforts to enhance product safety and performance.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities of this position include, but are not limited to the following:
Complaint Management:
- Receive, document, and track customer complaints related to medical devices.
- Conduct thorough investigations of complaints to determine root cause and identify corrective actions.
- Ensure timely and accurate documentation of complaint investigations in accordance with regulatory requirements.
Post Market Surveillance:
- Support the development and implementation of post-market surveillance plans in compliance with relevant regulations (e.g., FDA, EU MDR).
- Collect and analyze post-market data from various sources, including customer feedback, clinical studies, and adverse event reports.
- Monitor and evaluate product performance and safety trends to identify potential issues.
Regulatory Reporting:
- Prepare and submit required regulatory reports (e.g., Medical Device Reports, Vigilance Reports) to appropriate authorities.
- Maintain up-to-date knowledge of global regulatory requirements related to post-market surveillance.
Cross-Functional Collaboration:
- Work closely with Engineering, Operations, Quality and Regulatory teams to ensure effective communication and resolution of post-market issues.
- Provide support during internal and external audits and inspections.
Continuous Improvement:
- Identify opportunities for process improvements and contribute to the development and implementation of corrective and preventive actions (CAPAs).
- Support quality improvement initiatives to enhance product safety, performance, and customer satisfaction.
- Execute other quality and regulatory tasks as instructed by management.
REQUIRED SKILLSETS
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency in using complaint management systems and data analysis tools.
- Knowledge of relevant regulations and standards preferred (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
- Ability to work independently and collaboratively in a team environment.
COMPETENCIES
- Adaptability/Flexibility
- Ethical Conduct/Integrity
- Communication/Listening
- Detail-Oriented
- Interpersonal skills
- Personal Effectiveness
- Teamwork
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, & ABILITIES)
- Strong organization and time management skills with the demonstrated ability to meet deadlines
- Familiar with complaint handling, CAPA, Non-conforming material processes, including root cause analysis techniques
- Ability to work independently and within a team environment
- Exercises judgement within broadly defined practices and policies
- Outstanding communication skills
- Ability to work with all levels of company staff
- Experience with electronic quality or document management systems (or other documentational software)
- Experience working in a highly regulated environment
- Exceptional skills in using basic computer software and hardware applications, including Microsoft Word and Excel
PREFERRED QUALIFICATIONS
- Bachelor’s Degree or equivalent in life science or engineering field
- 1-3 years’ experience in medical device quality assurance discipline.
- Experience with FDA inspections and/or Notified Bodies Audits desirable
- Experience in ERP and eQMS systems
- Certified internal auditor
SUPERVISORY RESPONSIBILITY
This position has no supervisory responsibilities. This position may be required to lead/report on projects and ensure participants meet deadlines.
WORK ENVIRONMENT
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This is a full-time position.
Days and hours of work are typically Monday through Friday, 8:30 a.m. to 5 p.m.
This job may also operate in a cleanroom environment. Cleanroom environment requires personnel to wear company-provided cleanroom attire; e.g. scrubs, coat, bouffant, face mask, and gloves.
- Must be able to stand or sit for extended periods of time. Must be able to wear personal protective equipment when required
PHYSICAL DEMANDS & WORK ENVIRONMENT
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is frequently required to stand, walk, climb, sit, stoop, bend and reach with hands and arms. The employee must frequently lift and/or move up to 50 pounds and may be required to operated automated warehouse equipment; e.g. electric pallet jack, forklift. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus.
NOTE
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.