Medical Device Technical Writer Job at Joulé, Lansdale, PA

Z053akFJc0xpazlGbFZGYkpzckFEU2sv
  • Joulé
  • Lansdale, PA

Job Description

Job Title: Medical Device Technical Writer Location: Rahway, NJ or West Point, PA (Hybrid) Hours/Schedule: Mon- Fri 8am- 5pm Type: Contract Overview Global Pharma company looking to hire an experience Technical Writer to join their team. Must have experience with Medical Devices, technical assessments and writing of change controls, and a BS Degree. This is not an IT role. Responsibilities The basic function of this position is to author technical change assessment related to medical devices and to provide support to customer complaints including ensuring the root cause appropriately considers the device and device constituents, author technical and risk assessment related to the device design change, and document the device risk analysis from complaints. Team supports multiple Medical Device and Combination Products (MDCP), such as vaccine prefilled syringes and devices. Requirements Bachelors in Science, Engineering or related field. Can be a mix of Co-op and real world experience (3-5+ years). Has experience in authoring design control documentations per 21 CFR 820.30 or device risk document per ISO 14971. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical abilities. Work requires experience in engineering change assessment, root cause investigations and device risk document management. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. The candidate will work with a small team that supports life-cycle management activities of medical device combination products. Proven problem solving abilities. Demonstrated written and verbal communication skills. Preferred skillsets- Medical device combination product background/experience, understanding root cause, deviation management and change management. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Joulé

Job Tags

Contract work,

Similar Jobs

Lowes Foods

Cake Decorator PT Job at Lowes Foods

 ...interactions with all guests. 2. Prepare product for sale (icing, decorating, pricing, packaging and labeling). 3. Maintain product level,...  ...to read dates of icings) and scrapes down buckets. 12. Use cake manual as reference material. 13. Write on cakes. 14.... 

Spectrum Health Systems, Inc.

Master’s level Clinical Manager Job at Spectrum Health Systems, Inc.

 ...educationally diverse staff and patients. Excellent time management and organizational skills Strong Computer skills, including...  ...Must have access to an operational and insured vehicle The Clinical Care Manager is responsible for: Collaborating with team members... 

The Orthopaedic Institute

IT MANAGER Job at The Orthopaedic Institute

Job TypeFull-timeDescriptionJOB OVERVIEW:The IT Director is responsible for providing tactical direction to assist in leveraging...  ...telecommunications and electronic medical recordOversee and manage the IT global budgetPrepare and maintain technical specs and... 

Robert Half

Sponsorship Manager Job at Robert Half

100% onsite in New Brunswick, NJ REQUIRED Salary: $70-80K MAX Manager of Sponsorships and Membership Growth to drive membership expansion and develop sponsorship opportunities. This role is pivotal in growing their member base and managing a diverse portfolio of... 

Johnson Security Bureau, Inc.

Security Officer Construction Site Job at Johnson Security Bureau, Inc.

 ...Job Title : Security Officer Construction Site Location: Brooklyn, New York Join a Legacy of Excellence! Work Type: Part-Time EmploymentOpportunity Available Pay Rate: Competitive PayRate starting at$18.00 - $19.00/hr with Benefits Experience: 2 years...