Genesis10 is currently seeking a Quality Assurance Engineer working a contract with our client onsite in the healthcare industry in their Westborough, MA location.

Summary:
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

Key Responsibilities:

• Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
• Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools.
• Provides development and implementation support for process verification and validation plans, equipment qualification documents and Validation Plans (Product or Process specific plans). Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, action plans, and for corrective and preventive actions (CAPA Program).
• Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Failure Mode Analysis, etc.
• Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
• process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
• Reviews and approves manufacturing process change requests.
• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Qualifications:

• Bachelor's degree
• 5 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies
• Demonstrated experience using word processing, spreadsheet, and presentation software.
• Demonstrated understanding of continuous quality / process improvement tools.

Compensation: $60.00-80.00 per hour

If you have the described qualifications and are interested in this exciting opportunity, apply today!

About Genesis10:
Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year-in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

Benefits of Working with Genesis10:
Access to hundreds of clients, most who have been working with Genesis10 for 5-20 years.
The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.
Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)
Medical, Dental, Vision
Health Savings Account
Voluntary Hospital Indemnity (Critical Illness & Accident)
Voluntary Term Life Insurance
401K
Sick Pay (for applicable states/municipalities)
Commuter Benefits (Dallas, NYC, SF)
Remote opportunities available

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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