Sr. Development Quality Engineer

Westford, MA, US • Posted 1 day ago • Updated 17 hours ago
Contract W2
On-site
$46/hr
Company Branding Image
Fitment

Dice Job Match Score™

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Job Details

Skills

  • ("Sr. Quality Engineer" OR "Senior Quality Engineer" OR "Development Quality Engineer" OR "Design Quality Engineer" OR "Design Assurance Engineer") AND ("medical device" OR MedTech OR "implantable" OR "active implantable") AND ("design control" OR DHF OR "design history file" OR "requirements management") AND ("risk management" OR FMEA OR DFMEA OR PFMEA OR "ISO 14971") AND ("verification" OR "validation" OR V&V OR "test method validation") AND ("FDA" OR "21 CFR 820" OR "ISO 13485" OR MDR) AND (R&D OR "product development")

Summary

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Sneha Ranjan at email address can be reached on # .

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 Duration: 12+ months Pay Rate: $46/hour on W2


Screening Questions:

  • Can you walk me through your experience supporting Design Controls in a medical device product development lifecycle (e.g., requirements, V&V, design transfer)?
  • What type of risk management activities have you led or contributed to (e.g., FMEA), and at what stages of product development?
  • What experience do you have with medical device regulations (FDA, ISO 13485, EU MDR) and test method validation or verification activities?


Description:
The Sr. Development Quality Engineer will serve as a technical representative, providing design-quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

Responsibilities:

  • Lead and/or support on-time completion of Design Control deliverables
  • Support the establishment of objective, measurable, and verifiable product requirements
  • Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
  • Lead Risk Management activities from product concept through commercialization
  • Support test method development and lead test method validation activities
  • Support manufacturing process development & qualification for new products and design changes
  • Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support biocompatibility and sterilization qualifications
  • Support audits and quality system improvement activities
  • Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Comply with Abbott, U.S. FDA, EUMDR, and other requirements, as applicable.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.


Basic Qualifications:

  • Bachelor s degree in Engineering or Technical Field.
  • Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
  • Experience in medical devices and associated regulations/standards.
  • Experience in test method development and validation
  • Experience in preparing risk assessments, FMEA and other risk documents.


Preferred Qualifications:

  • Advanced Degree in Engineering/Technical Field
  • Experience in active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
  • Working knowledge of statistics and its application to verification and validation



To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Sneha Ranjan at email address can be reached on # .

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91013946
  • Position Id: 26-02449
  • Posted 1 day ago

Company Info

About Generis TEK Inc.

Generís Tek is an elite IT staffing firm headquartered in Chicago, IL offering long-term, short-term, temporary-to-permanent and direct placement staffing. We have 15 years of experience providing talented professionals to several Fortune 1000 clients. We are currently able to support clients across all locations within the United States with our unique client engagement models.

We at Generís Tek very highly value our relationship with our consultants. Our dedicated professionals help consultants reach their career objectives. We provide a competitive, fast-paced environment that promotes open communication to form a long term relationship built on mutual understanding, respect and trust. What sets us apart is the high level of service we provide to our clients after each employee is placed.

Our client relationships are backed by unparalleled understanding of workforce strategies, industry insight and expertise. As a trusted partner that has a strong recruiting focus, clients look at Generís Tek to meet their Talent acquisition needs. We have a solid database of qualified candidates that can be provided to our clients in quick turnaround time. 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. Our business heavily relies on technology that gives a seamless solution to our clients and consultants. We offer our client intelligence about the talent market which helps them in their decision making and formulating workforce strategies at an optimum cost. We aspire to be our clients most trusted business partner.

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