30 days old

Supplier Quality Engineer

Kelly Services
Lakewood, CO 80232
**Supplier Quality Engineer Lakewood, CO**


Kelly Engineering is currently seeking qualified candidates for a Supplier Quality Engineer III position in Lakewood, CO working for our client in the Medical Device/Pharma industry. This person will be responsible for working with Suppliers and Contract Manufacturing Organizations (CMO) to improving process reliability, repeatability, controls and resolution of quality issues. Supplier Quality Engineers must be proficient at process controls, project management, process validation and verification, process improvement, supplier auditing, supplier management, and CAPA investigations. Position will have a focus on process development, Quality plans, tool design and equipment requirements related to injection molding and die casting.

Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.


+ Supports relationship with key suppliers, including CMO(s) and acts as Point of Contact for resolution of technical issues and concerns

+ Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:o Tool Design and Process Development that drives zero defect approach to qualityo New Product Introduction (NPI)o Area of concentration includes Machining, Sheet Metal, and Assembly processeso Component, tooling, and process validations / verificationo Project management of supplier quality initiatives.o Supplier selection, evaluations, and auditso Corrective and Preventative Action (CAPA)

+ Perform independent evaluation, selection, and application in making adaptations and modifications to projects.

+ Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.

+ Manages and provides leadership for the functional groups development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

+ Implements and understands FDA or regulatory requirements as necessary.

+ Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas.

+ Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.

+ Advises team members pro-actively on technical ideas and promotes skill development of teamwork.

+ Interacts with peers across projects to secure resources and commitments.

+ Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.

+ Follows technical specification requirements and provides feedback on various technical processes and procedures.

+ Presents effectively complex technical information/analysis and responds to questions from technical staff members and management.

+ Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).


+ Work direction responsibility may include technicians and junior engineers.

+ May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.



+ Bachelors degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

+ Bachelor of Science Degree in Engineering. Mechanical, Industrial, or Biomedical preferred.

+ Master of Science Degree in Engineering, optional.


+ Minimum 4 years experience.

+ Two years of GMP manufacturing experience required.

+ Minimum 4 years of injection molding, die casting, or device manufacturing at contract manufacturers experience required


+ Requires demonstrated skills in technical innovation, technical leadership, mechanical and or chemical engineering, fluids engineering, and cellular biology.

+ Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.

+ Strong technical problem-solving skills.

+ Mechanical and electronic ability aptitude to assist with equipment troubleshooting.

+ Understanding of and adherence to GMP practices and FDA regulations.

+ Knowledge and ability to implement FDA or regulatory requirements as necessary.

+ Demonstrated ability to communicate effectively both verbally and in writing.

+ Knowledge and use of relevant PC software applications and skills to use them effectively.

-Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

**Target Salary Range:** $87,800 - $109,800 annually + Bonus*

***Target Bonus on Base:** 7.0%

**Why Kelly** **** **?**

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2021-08-20 Expires: 2021-09-20

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Supplier Quality Engineer

Kelly Services
Lakewood, CO 80232

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