Quality Engineer II - Exempt - LanceSoft Inc
Minneapolis, MN 55432
About the Job
Must Have:
2-5 Years Experience in Quality with BS in Engineering
a Manufacturing Quality Engineer II
Basic understanding of 21 CFR 820 and experience working in the Medical Device Industry
Quality
Strong supplier change control experience
Nice to Have:
A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T. Experience in mechanical assembly and components. Ability to work with vendors on dimensions and order components. Ability to qualify equipment in medical device mfg. assembly line. Experience in working in a med device company in a cleanroom environment.
• Ability to effectively facilitate team meetings, create and deliver presentations, and drive meetings to action-oriented decisions
Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical devices manufacturing Interpersonal Skills investigate and collaborate in the investigation of atypical events to support product disposition PFMEA
CAPA processes
Design Failure Mode and Effect Analysis (DFMEA)
Manufacturing Process Controls
non conformance
JOB DESCRIPTION
What are the top 3 things you are looking for in a candidates experience:
Medical Device supply chain/operations quality experience
Change control/Non conformance/CAPA processes
Technical degree
Education: B.S. in Engineering
Years of experience: 2-5 yrs
Work Location:
Do they need to be local to any MDT office and if so where? Rice Creek East
Does this person need to be on site? If so, full time or part time? Full time on site
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. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. 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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
2-5 Years Experience in Quality with BS in Engineering
a Manufacturing Quality Engineer II
Basic understanding of 21 CFR 820 and experience working in the Medical Device Industry
Quality
Strong supplier change control experience
Nice to Have:
A Bachelor in Mechanical or Electrical Engineering with ability to build custom fixtures. Ability to read drawings, BOMs, GD&T. Experience in mechanical assembly and components. Ability to work with vendors on dimensions and order components. Ability to qualify equipment in medical device mfg. assembly line. Experience in working in a med device company in a cleanroom environment.
• Ability to effectively facilitate team meetings, create and deliver presentations, and drive meetings to action-oriented decisions
Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical devices manufacturing Interpersonal Skills investigate and collaborate in the investigation of atypical events to support product disposition PFMEA
CAPA processes
Design Failure Mode and Effect Analysis (DFMEA)
Manufacturing Process Controls
non conformance
JOB DESCRIPTION
What are the top 3 things you are looking for in a candidates experience:
Medical Device supply chain/operations quality experience
Change control/Non conformance/CAPA processes
Technical degree
Education: B.S. in Engineering
Years of experience: 2-5 yrs
Work Location:
Do they need to be local to any MDT office and if so where? Rice Creek East
Does this person need to be on site? If so, full time or part time? Full time on site
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. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. 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. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Source : LanceSoft Inc
