(Contract) Senior Quality Engineer - 21 CFR Parts 210 and 211

Kymanox•Fort Lauderdale, FL

About The Position

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. We are looking for a meticulous (Contract) Senior Quality Engineer to carry out the following duties:

Requirements

7+ years' experience working in development and/or manufacturing in the pharmaceutical, biotechnology, combination product, and/or medical device sectors is required.
Experience with 21 CFR Parts 210 and 211 is required.
The ideal candidate will have a bachelor’s degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering.

Nice To Haves

Experience with pre-filled syringes, autoinjectors, co-packaged kits, other drug delivery platforms, and/or other combination products platforms is desired.
Familiarity with risk management tools and applications as well as data analysis tools and applications.
Understanding of ISO 13485 and FDA QMSR.

Responsibilities

Provides immediate project supervision and leadership.
Participates in and supports a matrixed team environment with organization and detail-orientated initiatives.
Reviews and/or approves technically complex documentation to ensure compliance with relevant standards and regulations.
Completes gap assessments against industry regulations or standards.
Participates in regulatory body inspections or remediation efforts.
Follows policies or standard operating procedures to support internal or client projects.
May support supply chain and vendor management strategy or compliance activities.
Completes assigned training requirements (internal and external).
Understands, authors, and reviews both the Combination Product Design History File and Risk Management File.
Understand and authors quality events such as CAPA, Deviations, OOS, Investigations, and Complaints.
May provide technical project management and meeting facilitation.