Redbock - an NES Fircroft company · 1 day ago
Quality System Specialist
United States
Full-time
Remote
Mid, Senior Level
$40/hr - $50/hr
4+ years expRedbock - an NES Fircroft company is looking for a Sr Quality Systems Specialist for a 12-month contract role. The individual will provide oversight for the development and maintenance of quality programs and systems to ensure compliance with policies and regulatory standards in a medical device setting.
BiotechnologyConsultingMedical DevicePharmaceutical
Hiring Manager
Tony Nicolosi
Responsibilities
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
Coordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
Qualification
Required
Requires a Bachelor's Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Proficient in Agile systems for change control, technical writing, developing MS PowerPoint presentations, and project management support for Quality Management System processes relative to production and process controls within regulated industry
Quality Systems Management experience (e.g., process ownership, auditor, document owner) in the area of Production and Process Controls sub-processes in regulated industry
Project leadership or management experience
QMS Document change management knowledge
Familiarity with Microsoft Office suite of applications
Preferred
Lean / Six Sigma certification
Statistical analysis experience (e.g., acceptance sampling plans, test method validation, process validation, design of experiments)
Problem solving, communication, organizational skills
Experience in risk mitigation
Experience in medical device environment
Understanding of FDA regulations (21 CFR 820 and Part 11) and ISO 13485
Strong analytical, process improvement, critical thinking, and decision-making skills
Company
Redbock - an NES Fircroft company
Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.
51-200 employees
H1B Sponsorship
Redbock - an NES Fircroft company 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
2025 (8)
2024 (5)
2023 (1)
2022 (1)
2021 (8)
2020 (9)
Funding
Current Stage
Growth StageTotal Funding
unknown2018-06-20Acquired
Company data provided by crunchbase