Technical Complaint Specialist

This is a remote position.

CONTRACT FULLTIME

Reports to Director Quality Engineering

Our client is a leading organization dedicated to enhancing the production of modern medicine in the biotechnology pharmaceutical and medical device industries. With a strong commitment to quality safety and affordability they offer unparalleled contract services supported by a highly collaborative team of engineering compliance and project management experts.

Group:

Combination Products Quality Engineering

Educational Background:

Bachelor s degree in Biomedical Mechanical or Chemical engineering or other scientific discipline from an accredited institution or equivalent. Continuing education or certificates in project management sixsigma statistics engineering quality or regulatory affairs is desirable but not required.

Experience:

3 years of experience in postmarket surveillance in the medical device sector or manufacturing quality compliance in the pharmaceutical biotechnology combination product sector is required. Hands on experience with investigations corrective actions or product technical complaints are required. Working knowledge of ISOCFR 820 and ISO 14971 are not required but highly desired.

A demonstrated level of medical device and biologic and/or drug experience is required; overall talent and ability to learn from our clients experts is ultimately more important than current experience for longterm success at the firm.

Familiarity and experience with Class I and Class II devices (i.e.: prefilled syringes auto pen injectors copackaged kits and/or other combination product platforms) is desired.

Job Description:

The position will be engaged in leading key aspects of our client s service offerings and supporting clients covering postmarket surveillance activities compliance and life cycle management challenges related to complex combination products (e.g. biologicdevice drugdevice). Work under the guidance of our clients management and senior resources with support of multiple experienced technical project managers. Work closely with clients at their offices or remotely.

Projects may include any of the following focus areas:

• Product Technical Complaints
  
• Deviation Investigations
  
• Root Cause Analysis
  
• Corrective and Preventative Actions
  
• Medical Device Design Controls (e.g. DHF support)
  
• Risk Management Files
  
• Process Improvement and Troubleshooting
  
• Data Analysis Including Statistical Analysis
  
• Strong Technical Writing Authorship Review and Formatting
  
• Manufacturing and Complaint Investigations
  
• Quality Management Systems (QMS) Support
  

Additional responsibilities can include:

• Author technically simple and complex documentation to ensure technical competence to relevant local and federal regulations.
  
• Familiarity with risk management tools and applications
  
• Familiarity with data analysis tools and applications
  
• Others as applicable
  

Desired Aptitude and Skill Set:

• Excellent written and oral English communication skills
  
• Resourceful
  
• Extremely detail oriented
  
• Ability to work effectively with remote team members and/or direct reports
  
• Highly organized
  
• Selfdirecting selfpacing
  
• Understanding of own limitations
  
• Ability to solicit and utilize subject matter expert input
  
• Fast learner
  
• Pleasant and positive communication style
  
• Strong customerservice aptitude
  
• Excellent problemsolving skills
  
• Soft skills (i.e. high EQ)
  
• Team player
  
• Thrive in a fastpaced growing and dynamic work environment
  
• Technology savvy
  

Requirements

1. Computer/Devices

• Reliable Desktop or Laptop: Ideally with at least 8GB of RAM a fast processor (e.g. Intel Core i5 or above) and sufficient storage (256GB SSD or higher).
  
• Backup Device: A tablet or second computer can be handy if the primary device encounters issues.
  

2. Internet Connection

• HighSpeed Internet: A stable connection with at least 25 Mbps download speed and 5 Mbps upload speed is recommended for video calls file sharing and cloudbased work.
  
• Backup Internet: A mobile hotspot or second broadband connection in case of outages.
  

3. Workspace

• Quiet Workspace: A dedicated and quiet space free from distractions for focus.
  
• Ergonomic Office Chair and Desk: To maintain posture and reduce strain.
  

4. Backup Power (Optional)

• Power Backup: UPS or a portable power station in case of prolonged power outages.
  

Benefits

• Permanent Work From Home