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Quality Engineering Lead - EU MDR Remediation
Actalent
Lead the quality workstream for a EU MDR remediation project in a leading medical device company, including gap assessment, technical file remediation, and team management.
15d ago
$50 - $55
Experienced (8-12 years), Expert & Leadership (13+ years)
Contractor
Aurora, CO
Onsite
Company Size
5,000 Employees
Service Specialisms
Technical consultation
Performance analysis
Physical development
Injury prevention and recuperation
Sports psychology
360° Marketing
Consultancy with clubs and sporting entities
Legal services
Sector Specialisms
Utilities
Power
Automotive
Food and Beverage
Consumer Products
Industrial Goods
Manufacturing
Mechanical Engineering
Role
What you would be doing
compliance remediation
team management
documentation review
quality strategy
regulatory oversight
gap assessment
- Drive the remediation of technical files to meet EU MDR requirements.
- Oversee and guide an offshore Quality Lead to ensure alignment and consistency.
- Review existing technical documentation and identify compliance gaps.
- Develop and implement quality strategies and documentation updates.
- Provide quality oversight and ensure adherence to regulatory standards and internal procedures.
- Collaborate with cross-functional teams to gather necessary inputs.
- Lead the execution of the quality portion of the EU MDR gap assessment.
- Manage a larger team of quality professionals, ensuring timely and compliant deliverables.
What you bring
team management
consulting experience
bachelor’s degree
7+ years
leadership skills
regulatory knowledge
- Experience managing remote and offshore teams.
- Prior consulting experience in medical device regulatory projects.
- Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
- Minimum 7 years of experience in medical device quality assurance.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- EU MDR
- Proven experience with EU MDR compliance and technical documentation.
- Excellent communication, leadership, and project management skills.
- Strong understanding of ISO, 21 CFR Part 820, and global regulatory requirements.
- Health Spending Account (HSA)
- Medical, dental & vision
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Critical Illness, Accident, and Hospital
- Gap Assessment
- Short and long-term disability
- Transportation benefits
- Employee Assistance Program
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Time Off/Leave (PTO, Vacation or Sick Leave)
Information not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearance- yes, background checks may be part of the hiring process
Company
Overview
$1.3B Annual Revenue
Revenue Figure
Generated annually through a network of technical and consulting services.
27,500+ Consultants
Consultants Network
Comprises a global network of expert professionals across industries.
- Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner.
- Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services.
- Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects.
- Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems.
- Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.
- We empower people to realize their full potential by providing opportunities to grow and learn.
- We build lasting relationships based on trust, integrity, and respect.
- We champion innovation, continuously seeking creative solutions.
- We are committed to delivering exceptional results for our clients and employees.
- We foster a collaborative environment where team members contribute to collective success.
2050
Target Year
The company has set a goal to achieve net-zero emissions by the year 2050.
- focused on reducing its carbon footprint and enhancing environmental sustainability.
- committed to making energy-efficient investments and improving operational practices for sustainability.
- focuses on reducing waste and increasing recycling in its operations.
- This company prioritizes creating an inclusive workplace where diverse perspectives are valued.
- The organization strives to increase gender diversity and empower women at all levels.
- The company regularly monitors and tracks progress on gender-related diversity goals.
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