Senior Quality Engineer - Medical Device - Only W2
- Full Time, onsite
- Taras Technology LLC
- Hybrid3 days onsite and 2 days Remote in a Week, United States of America
TECHNICAL SKILLS
Must Have
Advanced Project Quality Engineering Specialist
Nice To Have
EUMDR experience
JOB DESCRIPTION
This position will support all cardiac surgery EU MDR implementation projects to create/ review and approve change orders, redline the technical documentation, actively lead the label verification process in collaboration with quality engineers at Grand Rapids. Support all other EU MDR related deliverables for the MDR team as appropriate.
Top 3 technical skills that are required for the role:
Quality Engineer experience at medical device
Work in the fast pace environment
MDR experience is preferred
Education Required:
University degree e.g. Bio medical Engineering, mechanical engineering, Biology, or similar.
Years Experience Required: 4
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite or hybrid (with mandatory 3 days onsite including Monday, Wednesday & Fridays or rotation to support when necessary)
What is your timeline for scheduling interviews? As soon as possible
What product line will this person support? Cardiac Surgery
Responsibilities:
Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Accountable for the successful implementation of the outcomes the EU MDR implementation projects, EU MDR remediation assignment.
Prioritization of the projects deliverables at Grand Rapids. Support label verification process, inspection, FAI, and other Grand Rapids related QE activities to move the MDR projects in a timely manner. Review and approve change orders that are related to MDR projects and ensure the quality aspect of the projects are reviewed and in compliance.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed). IQ, OQ and PQ performance and review if needed.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Taras Technology, LLC is an EEO/AA Employer: women, minorities, the disabled and veterans are encouraged to apply
TECHNICAL SKILLS
Must Have
Advanced Project Quality Engineering Specialist
Nice To Have
EUMDR experience
JOB DESCRIPTION
This position will support all cardiac surgery EU MDR implementation projects to create/ review and approve change orders, redline the technical documentation, actively lead the label verification process in collaboration with quality engineers at Grand Rapids. Support all other EU MDR related deliverables for the MDR team as appropriate.
Top 3 technical skills that are required for the role:
Quality Engineer experience at medical device
Work in the fast pace environment
MDR experience is preferred
Education Required:
University degree e.g. Bio medical Engineering, mechanical engineering, Biology, or similar.
Years Experience Required: 4
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite or hybrid (with mandatory 3 days onsite including Monday, Wednesday & Fridays or rotation to support when necessary)
What is your timeline for scheduling interviews? As soon as possible
What product line will this person support? Cardiac Surgery
Responsibilities:
Responsibilities may include the following and other duties may be assigned.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Accountable for the successful implementation of the outcomes the EU MDR implementation projects, EU MDR remediation assignment.
Prioritization of the projects deliverables at Grand Rapids. Support label verification process, inspection, FAI, and other Grand Rapids related QE activities to move the MDR projects in a timely manner. Review and approve change orders that are related to MDR projects and ensure the quality aspect of the projects are reviewed and in compliance.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products, labels, IFus and production equipment (if needed). IQ, OQ and PQ performance and review if needed.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Taras Technology, LLC is an EEO/AA Employer: women, minorities, the disabled and veterans are encouraged to apply