Website Artech LLC
Artech LLC
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Company : Artech LLC
Job Title : Sr Quality Engineer
Location : 1480 Arthur Ave, Unit D, Louisville Colorado 80027
Duration : 12 Months
Job ID : 13212
Pay rate: $45-$55/hr On W2
Must Have:
Equipment and Software Validation Experience
Nice to Have:
Experience working in Medical Device Field
JOB DESCRIPTION:
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 incoming components and assist in resolving inspection issues. You will work on both Nonconformances and CAPAs.
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.
The Primary function of this position is to support Operations Quality while the site is working on a New Product Lauch of Capital Equipment. In this role, you will rewiew and approve validations (process, software, equipment) You will work hand in hand with Manufacturing Enigineering to develop Operator Work Instructions and set up assembly stations. You will work directly with Inspection Inspection to help establish inspection methods of new incoming components and assist in resolving inspection issues. In addtion 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. 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: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others’ work product . 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.
Spoorthi Raj G
Associate Recruiter
Office: (phone number removed)
Email: (url removed)
Website: (url removed)
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