Quality Engineer I - Exempt - LanceSoft Inc
Plymouth, MN 55442
About the Job
Must Have:
1 & 2 > 1 & 2 Bioengineering
• Experience in medical device manufacturing or manufacturing in highly regulated industry/environment.
Quality Engineering
Nice to Have:
Statistical Process Controls
Supplier Controls
JOB DESCRIPTION
Can you please confirm your top 3 skills sets required?
Operations support experience
Med device experience
Engaging personality
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
-Non-conformance management
-Manufacturing process improvement
-Change control/stats
What products (if any) will this role support? Self expending stents, metals processing, delivery systems (catheters)
What is your target years of experience? Any experience is a plus.
When do you plan to start interviewing? Next week.
Will you be looking to hire and start ASAP or will the start date be delayed? ASAP.
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Onsite.
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.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (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), 0 years of experience required.
1 & 2 > 1 & 2 Bioengineering
• Experience in medical device manufacturing or manufacturing in highly regulated industry/environment.
Quality Engineering
Nice to Have:
Statistical Process Controls
Supplier Controls
JOB DESCRIPTION
Can you please confirm your top 3 skills sets required?
Operations support experience
Med device experience
Engaging personality
Can you please confirm the 3 main responsibilities/day to day activities required for this role?
-Non-conformance management
-Manufacturing process improvement
-Change control/stats
What products (if any) will this role support? Self expending stents, metals processing, delivery systems (catheters)
What is your target years of experience? Any experience is a plus.
When do you plan to start interviewing? Next week.
Will you be looking to hire and start ASAP or will the start date be delayed? ASAP.
Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Onsite.
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.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, 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 R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Autonomy: Entry-level individual contributor on a project or work team.
Works with close supervision.
Organizational Impact: Delivers work of limited scope, typically smaller, less complex projects or related activities.
Innovation and Complexity: Identifies, defines and addresses problems that are not immediately evident but typically not difficult or complex.
Makes minor changes in systems and processes to solve problems.
Communication and Influence: Communicates primarily with internal contacts within immediate group.
Contacts others to gather, confirm and convey information.
Leadership and Talent Management: N / A – job at this level is focused on self-development.
Required Knowledge and Experience: Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (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), 0 years of experience required.
Source : LanceSoft Inc