Sr Quality Engineer - Artech LLC
Louisville, CO 80027
About the Job
Job Title: Sr Quality Engineer
Location: Louisville Arthur, 1480 Arthur Ave, Louisville Colorado 80027
Duration: 12 months
Job ID: 15730
Pay Rate: $50-$55/hr.
ALTERNATE JOB TITLE:
OPS New Product QE
JOB DESCRIPTION:
The Primary function of this position is to support Operations Quality while the site is working on a New Product Launch of Capital Equipment. In this role, you will review and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection to help establish inspection methods of incoming components and assist in resolving inspection issues. In addition, this person will assume ownership of any NCMR or CAPA that is created from Operations Quality.
Top 3 technical skills that are required for this role:
Experience with Medical Device MFG.
Experience with owning and processing NCMRs and CAPA
Experience with reviewing Validations.
Education Required: 4 years B.S. in Engineering or Science related field.
Years’ Experience Required: 5 years
Will the contractor be working 40 hours a week? Will there be any overtime and if so approximately how much per week? 40 hour week, no OT is planned.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite
What is your timeline for scheduling interviews? 1-2 weeks
What product line will this person support? StealthStation S8, Stealth Axis, Visualase, Kitting
In addition to the primary task, 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.
Ideal candidate will be a seasoned individual contributor that works independently under limited supervision. Candidate should be able to successfully navigate between project work and addressing the day to day needs of manufacturing. Candidate should be comfortable reviewing and approving Software, Process and Equipment Validations. Candidate should be able to coach and influence other Manufacturing Engineer to ensure compliance with Quality Requirements. Requires a 4 year degree in Engineering or Computer Science and minimum of 4 years of relevant experience.
Top 3 technical skills that you are required for the role:
Software, Process and Equipment Validation experience
Experience working in Medical Device or other government regulated industries.
Ability to multi-task and handle both project work and day to day activities.
Education Required: 4-year degree in Engineering or Computer Science
Years’ Experience Required: 4 years
Will the contractor be working 40 hours a week? If not, weekly estimate? – 40 hours
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? – This is an onsite role
What is your timeline for scheduling interviews? - Ideally starting next week
What product line will this person support? – Production of Capital Equipment. Production of Accessory Kits that support Capital Equipment. Launch support for a new Capital Equipment system.
The Primary function of this position is to support Operations Quality while the site is working on a New Product Launch of Capital Equipment. In this role, you will review and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection to help establish inspection methods of new incoming components and assist in resolving inspection issues. In addition to the primary task, 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.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Thank You
Yadav Anoop
Associate Recruiter
Location: Louisville Arthur, 1480 Arthur Ave, Louisville Colorado 80027
Duration: 12 months
Job ID: 15730
Pay Rate: $50-$55/hr.
ALTERNATE JOB TITLE:
OPS New Product QE
JOB DESCRIPTION:
The Primary function of this position is to support Operations Quality while the site is working on a New Product Launch of Capital Equipment. In this role, you will review and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection to help establish inspection methods of incoming components and assist in resolving inspection issues. In addition, this person will assume ownership of any NCMR or CAPA that is created from Operations Quality.
Top 3 technical skills that are required for this role:
Experience with Medical Device MFG.
Experience with owning and processing NCMRs and CAPA
Experience with reviewing Validations.
Education Required: 4 years B.S. in Engineering or Science related field.
Years’ Experience Required: 5 years
Will the contractor be working 40 hours a week? Will there be any overtime and if so approximately how much per week? 40 hour week, no OT is planned.
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite
What is your timeline for scheduling interviews? 1-2 weeks
What product line will this person support? StealthStation S8, Stealth Axis, Visualase, Kitting
In addition to the primary task, 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.
Ideal candidate will be a seasoned individual contributor that works independently under limited supervision. Candidate should be able to successfully navigate between project work and addressing the day to day needs of manufacturing. Candidate should be comfortable reviewing and approving Software, Process and Equipment Validations. Candidate should be able to coach and influence other Manufacturing Engineer to ensure compliance with Quality Requirements. Requires a 4 year degree in Engineering or Computer Science and minimum of 4 years of relevant experience.
Top 3 technical skills that you are required for the role:
Software, Process and Equipment Validation experience
Experience working in Medical Device or other government regulated industries.
Ability to multi-task and handle both project work and day to day activities.
Education Required: 4-year degree in Engineering or Computer Science
Years’ Experience Required: 4 years
Will the contractor be working 40 hours a week? If not, weekly estimate? – 40 hours
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? – This is an onsite role
What is your timeline for scheduling interviews? - Ideally starting next week
What product line will this person support? – Production of Capital Equipment. Production of Accessory Kits that support Capital Equipment. Launch support for a new Capital Equipment system.
The Primary function of this position is to support Operations Quality while the site is working on a New Product Launch of Capital Equipment. In this role, you will review and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Engineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection to help establish inspection methods of new incoming components and assist in resolving inspection issues. In addition to the primary task, 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.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.
Thank You
Yadav Anoop
Associate Recruiter
Source : Artech LLC
