Website Generis Tek Inc.
Generis Tek Inc.
Company : Generis Tek Inc.
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address (url removed) can be reached on # (phone number removed).
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 Monu Karwasara at email address (url removed) can be reached on # (phone number removed).
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.