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Sr. Development Quality Engineer

Generis Tek Inc.

Westford, MA

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JOB DETAILS
SALARY
SKILLS
Communication Skills, Cross-Functional, Customer Relations, Customer Satisfaction, Design Verification, Document Management, FDA (Food and Drug Administration), Fortune 500 Customers, Healthcare Quality, Leadership, Maintain Compliance, Manufacturing/Industrial Processes, Medical Equipment, Medical Products, Patient Safety, Philosophy, Problem Solving Skills, Process Development, Product Development, Product Lifecycle, Product Support, Product/Service Launch, Quality Assurance, Quality Assurance Methodology, Quality Engineering, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Risk Analysis, Risk Management, Safety Compliance, Sterilization, Technical Support, Test Plan/Schedule, Time Management, Validation Plan, Validation Testing, Vendor/Supplier Planning
LOCATION
Westford, MA
POSTED
7 days ago
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address  

Nikhil.Jhajharia@generistek.com

 can be reached on # (630) 576-1935.
 
We have Contract role Sr. Development Quality Engineer for our client at Westford, MA. Please let me know if you or any of your friends would be interested in this position.
 
Position Details:
Sr. Development Quality Engineer- Westford, MA
Location                       : Westford, MA – 01886 (100% Onsite)
Project Duration      : 10 Months of contract
Pay Rate                       : $49.50 per hour on W2
 
PositionPurposeandScope:

Top 3 Technical Skills:The Sr. Development Quality Engineer serves as a technical quality representative supporting product development teams. This role provides design quality expertise across the product lifecycle to ensure patient and user safety, regulatory compliance, and customer satisfaction. The position partners closely with cross functional stakeholders to deliver compliant, high quality medical devices from concept through commercialization.
  • Design Controls & Risk Management – Proven experience leading and supporting design control deliverables, risk assessments, and FMEAs throughout product development.
  • Verification, Validation & Test Methods – Expertise in test method development, validation, and execution of design verification and validation activities.
  • Medical Device Quality & Regulations – Strong working knowledge of FDA, EU MDR, and medical device quality system requirements, including audits and compliance activities.
    Additional Requirement: Clear and effective communication skills are a must.
Education:
  • Bachelor’s degree in Engineering or a related technical field (required).
  • Advanced degree in Engineering or a technical field (preferred).
Experience / Project Details:
  • Minimum 2–5 years of experience supporting medical device product development
  • Project focus: Class II imaging device
  • This role will support new product development, with multiple imaging-related projects in progress
Day-to-Day Responsibilities:
  • Lead or support timely completion of design control documentation
  • Collaborate with cross-functional teams to establish clear, measurable, and verifiable product requirements
  • Support design verification and validation planning, execution, and issue resolution activities
  • Lead risk management activities from product concept through commercialization
  • Support test method development and lead test method validation efforts
  • Collaborate with manufacturing on process development and qualification for new or updated designs
  • Support component specification development, supplier sampling plans, and vendor qualification activities
  • Support biocompatibility and sterilization qualifications
  • Participate in audits and continuous quality system improvement initiatives
  • Ensure compliance with Abbott quality systems, FDA, EU MDR, and other applicable regulatory requirements
  • Maintain effective communication with employees, suppliers, contractors, and customers
 
 
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address  

Nikhil.Jhajharia@generistek.com

 can be reached on # (630) 576-1935.
 
About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.
 

About the Company

G

Generis Tek Inc.

With over 15 years of experience servicing Fortune 500 customers across the globe, Generis Tek is consistently regarded as a pioneer in the IT and Professional Staffing and Services Industry. Finding the right talent for the job is a tough task, but it’s one we do especially well.
Generís Tek offers wide scope of services from strategizing to implementing that addresses these unique workforce challenges. Our professionals quickly adapt to clients work culture and become a core part of their team. We hire professionals as well as fresh grads from various disciplines to meet our client’s demands. Our focus is to create and manage a seamless stream of resources for a diverse, global, and effective talent pool. Working closely with our clients has enabled them to achieve their strategic objectives, leverage technological innovation and be cost effective.
We are driven by three core principles in changing Staff Augmentation for the better: cost, quality, and responsiveness. 
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2015
WEBSITE
http://www.generistek.com

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