Quality Assurance Specialist I

Job Description

Job Description

Job Overview:

Pay Range: $31.00hr - $36.00hr

Requirement/Must Have:

• Two or more years of experience in Quality or a related function.
• Bachelor's / Master's degree in Life Science, Data Science, or a related subject or equivalent experience.
• Professional experience in a similar role within the medical device sector.
• Knowledge of deviation and resolution management.
• Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.
• Strong analytical skills with a focus on essential facts.
• Strong verbal and written communication skills.
• Cultural awareness and experience interacting with global internal and external partners and suppliers.
• Leadership mindset with the ability to lead others within an agile organization.
• Willingness and flexibility to collaborate cross-continentally in a global team across different time zones (may require early working hours to ensure close collaboration with colleagues in the XX Union).
• Decisive and able to initiate and complete daily activities and proactively find solutions independently with limited guidance.

Responsibilities:

• Manage the ETE IVDR/MDR product verification process for products within distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.
• Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
• Complete onboarding activities for suppliers.
• Monitor supplier performance.
• Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
• Identify and escalate issues as they arise and provide adequate solutions.

Skills:

• Quality Assurance.
• Medical Device Sector.
• ISO 13485.
• ISO 27001.
• Supplier Quality Management.
• SCARs.
• IVDR/MDR.
• Supplier Audits.
• Analytical Skills.

Qualification And Education:

• Bachelor's or Master's degree in Life Science, Data Science, or a related field.

Benefits:

Our Benefits Include:

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

Disclaimer : Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.