Kymanox · 3 weeks ago
(Contract) Senior Quality Engineer - 21 CFR Parts 210 and 211
Fort Lauderdale, FL
Contract
Onsite
Senior Level
7+ years expKymanox is a life sciences professional services company dedicated to delivering high-quality solutions in the biotechnology and pharmaceutical industries. They are seeking a meticulous Senior Quality Engineer to provide project supervision, ensure compliance with standards, and support regulatory efforts.
Life ScienceTechnical Support
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
Qualification
Required
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
The ideal candidate will have a bachelor's degree in a science-related field such as Biomedical Engineering, Mechanical Engineering, or Chemical Engineering
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
Understanding of ISO 13485 and FDA QMSR
Preferred
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
Company
Kymanox
Kymanox is a technical products & project management company provides engineering, scientific, regulatory, and process operations support.
201-500 employees
H1B Sponsorship
Kymanox has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (1)
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknown2021-08-23Debt Financing
2021-08-02Series Unknown
Leadership Team
Stephen M. Perry
CEO
Nicholas Ciccarelli
Chief Technology Officer
Recent News
EIN Presswire
2025-05-08
GlobeNewswire News Room
2024-11-29
Company data provided by crunchbase