Quality Engineer II - Exempt - LanceSoft Inc
North Haven, CT 06473
About the Job
Must Have:
• 0-3 years of medical / clinical experience or exposure
analysis of protocols and make recommendations
analysis of validation plans and test protocols
Applied knowledge of basic statistics
GDP
Qualification Test Report
JOB DESCRIPTION
Please provide a brief description of what the role entails and day to day responsibilities.
Support the work from the test team which entails prioritizing, reviewing, and providing feedback and direction on test plans and reports. Providing guidance on appropriate testing methods, sample sizes, and acceptance criteria, and then ensuring the report acceptance criteria satisfies the design intent.
Top 3 technical skills that you are required for this role (please be detailed):
Engineering Report reviews, challenging the completeness and test results to ensure design requirements are satisfied through sufficient test evidence
Statistical analyses & tools
Understanding of complex systems operation and software controlled devices
Education Required:
Baccalaureate degree in Engineering or Statistics preferred, would consider also other technical science degrees
(or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
Years’ Experience Required:
Minimum of 2 years of relevant experience
Will the contractor be working 40 hours a week? Will there be any overtime required?
40 hours per week is standard expectation, could be potential for overtime depending on project schedules and work volume
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Onsite preferred (could be Boston, MA or North Haven, CT),
Hybrid onsite would be acceptable with 3 days per week onsite
What is your timeline for scheduling interviews?
ASAP
What product line will this person support?
Hugo RAS
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.
• 0-3 years of medical / clinical experience or exposure
analysis of protocols and make recommendations
analysis of validation plans and test protocols
Applied knowledge of basic statistics
GDP
Qualification Test Report
JOB DESCRIPTION
Please provide a brief description of what the role entails and day to day responsibilities.
Support the work from the test team which entails prioritizing, reviewing, and providing feedback and direction on test plans and reports. Providing guidance on appropriate testing methods, sample sizes, and acceptance criteria, and then ensuring the report acceptance criteria satisfies the design intent.
Top 3 technical skills that you are required for this role (please be detailed):
Engineering Report reviews, challenging the completeness and test results to ensure design requirements are satisfied through sufficient test evidence
Statistical analyses & tools
Understanding of complex systems operation and software controlled devices
Education Required:
Baccalaureate degree in Engineering or Statistics preferred, would consider also other technical science degrees
(or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A)
Years’ Experience Required:
Minimum of 2 years of relevant experience
Will the contractor be working 40 hours a week? Will there be any overtime required?
40 hours per week is standard expectation, could be potential for overtime depending on project schedules and work volume
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Onsite preferred (could be Boston, MA or North Haven, CT),
Hybrid onsite would be acceptable with 3 days per week onsite
What is your timeline for scheduling interviews?
ASAP
What product line will this person support?
Hugo RAS
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
