What are the responsibilities and job description for the Supplier Quality Engineer position at Koya Medical and Careers?
Koya is always looking for curious and passionate individuals who want to join a fast- paced team for a career in transforming venous and lymphatic care through innovative people-centric technologies that improve lives and empower self-care. Koya values integrity, humility, hard-work, camaraderie, and fun. We offer a base bonus compensation package, and a competitive benefits program.
About Koya Medical
Koya Medical, a privately held company founded in 2018, is a transformative healthcare company developing breakthrough treatments for venous diseases and lymphedema to enable joint contractions, patient mobility, and personalized care that is unavailable with traditional compression therapy. Koya is always looking for curious and passionate individuals who want to join a fast-paced team for a career in transforming venous and lymphatic care through innovative people-centric technologies that improve lives and empower self-care. Koya values integrity, humility, hard-work, camaraderie, and fun. We offer a base bonus compensation package, and a competitive benefits program.
Description
Job Summary
The Supplier Quality Engineer will be responsible for ensuring the safety and quality of our products throughout the development lifecycle, as related to our supply chain. You will work to develop suppliers, and support them in corrective and preventive action, as well as continuous improvement. You will work closely with cross-functional teams to enable our suppliers to address quality issues, drive continuous improvement of products/processes, and contribute to building high-quality products that exceed customer expectations. Your contributions will ensure that our innovative devices meet the highest standards of safety and performance, while adhering to regulatory requirements.
This position will report to the Quality Engineer. The role is full time, exempt, and will be based in Dallas, TX.
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Management of Supplier Corrective Actions (SCARs), reworks, CAPA, Design Changes, complaints, scrap and change requests related to suppliers.
- Guiding suppliers to develop quality control plans by identifying critical control points and implementing preventive measures or test methods, understanding machine or material process limits, monitoring production inspection results, and advising on quality procedures.
- Owning supplier quality, working cross-functionally with Procurement, R&D, and QC, to implement design controls for pipeline products at our suppliers, and with Manufacturing Operations to maintain risk and process documentation related to
the supply chain.
- Participating in the nonconformance system (NC) including root cause analysis, corrective action implementation and validation, as related to the supply chain.
- Setting and achieving KPI objectives by developing supplier data collection process, collecting and analyzing data, and implementing continuous improvement initiatives.
- Providing Supplier Quality expertise to Product Engineering/Design projects.
Supporting design review and tolerances definition in line with supplier process capabilities.
- Supporting supplier process validation and verification, test method validation, and equipment validation.
- Reviewing drawings and quality documentation.
Minimum Qualifications
Education, Experience and Training
- Bachelor of Science in engineering or a related field
- At least 3 years of experience in a Quality Engineering role in the medical device industry or an equivalent combination of education, training, and experience
- Experience in supplier quality engineering, particularly with East Asia suppliers preferred. Experience with a broad range of raw material types is desired; soft good experience is a plus.
- CQE and/or Lean Six Sigma experience preferred.
- APQP/PPAP experience preferred.
Knowledge, Skills and Abilities
- Resourcefulness, critical thinking and problem-solving skills
- A logical and planned approach to all tasks
- Takes initiative in everyday work
- Exceptional attention to detail
- Excellent understanding of GD&T
- Excellent understanding of ISO 13485, ISO 14971, and applicable FDA CFRs
- A working knowledge of regulatory requirements
- Strong data collection and analysis skills
- Strong understanding of process controls and validation
- Ability to perform root cause analysis and corrective action
- Must understand and be able to develop and document inspection methods and practices
- Verbal and written communication skills
- Able to work within a cross-functional team environment
- Able to work with overseas suppliers, including occasional travel
- Desire and ability to work in a fast-paced, dynamic environment
Core Competencies
Supplier Development, Continuous Improvement, Problem Solving, Change Agility, Stewardship
Tools and Technology
Arena PLM, SolidWorks, G Suite, Microsoft Office Suite, Adobe, Salesforce CRM
Physical Functions and Work Environment
The physical functions described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers; handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
Note
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties
requested by any Koya manager authorized to provide instruction or assign work. Duties, responsibilities, and activities may change at any time with or without notice. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.
Koya Medical, Inc. is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
Salary
$88,000 - $95,000 per year
Salary : $88,000 - $95,000