Sr Quality Engineer - Exempt
LanceSoft Inc
Job Description
Job Description
Join our team in West Valley City, UT, a vibrant location offering a perfect blend of urban amenities and natural beauty. This role provides an excellent opportunity to work in a dynamic environment where innovation and collaboration are at the forefront.
Must Have:- Design Quality Engineering
- Design Control
- Design Drawings
- Design History File Remediation
- Risk Management
- Statistics
- TMV
- Experience in New Product Development (NPD) or Design Quality
- Experience with design integration/DHF remediation
- Experience with vascular devices (catheters, stents, guidewires, etc.)
- Familiarity with design integration, design remediation, implementation of DFM principles, and supporting risk management architecture
- Bachelor's in Engineering or related Science
- Minimum of 5 years of experience
40 hours per week, full-time onsite in Salt Lake City, with no overtime expected.
Responsibilities:Responsibilities may include the following and other duties may be assigned:
- Develop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
- Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
- Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensure 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.
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 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 in-depth in nature and often provides recommendations on process improvements.
- Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
- 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.
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 a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
$83.3k - $133.28k
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