Supplier Quality Engineer Ii

JOB TITLE: Supplier Quality Engineer JOB SUMMARY Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity supporting projects for the new manufacturing facility in Costa Rica. Assignments include the responsibility for the quality of components and raw materials we receive from suppliers and resolving non-conformance issues that impact the medical devices, also supplier process improvements, reducing costs, and alleviating pain points that negatively affect manufacturing. Duties are assigned to provide experience and familiarization with quality methods, independent thinking, and company practices and policies. ESSENTIAL DUTIES Supports relationships with key suppliers and acts as the Point of Contact for resolution of technical issues and concerns. Works cross-functionally and proactively on supplier quality and management activities, including: Management of injection molding projects including tracking of project scope, schedule, and budget. Area of concentration includes Injection Molding, Thermoforming, and Extrusion for blood-contacting, disposable products Component, process validations (IQ/OQ/PQ), verification and final documentation Engineering Change Requests and Engineering Change Notices for supplier changes Engineering/technical documents such as protocols, reports, specifications, drawings, and vendor provided documents Statistical analysis including process capability, equivalency, and measurement system analysis (i.e. Gage R&R). Supplier quality performance, including corrective and preventive actions Implements and understands FDA or regulatory requirements as necessary Follows technical specification requirements and provides feedback on various technical processes and procedures Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions. Follows department processes and regularly makes recommendations on these processes. Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and responds to questions from technical staff members and management. Works cooperatively and effectively in a team environment or across teams to achieve common goals and results. Analyzes data and presents it in appropriate forums. Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation. OTHER DUTIES AND RESPONSIBILITIES Realize cost reductions and savings by partnering with new, low-cost suppliers. Alleviate pain points and disruptions in the manufacturing process by improving the quality of raw materials and components we receive from suppliers. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor's Degree in Engineering (Mechanical, Industrial, or Biomedical preferred) or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 4 years of experience working with manufacturing processes and a focus on quality. Skills Possesses and applies technical engineering knowledge. Must understand the fundamentals of mechanical engineering, how components are manufactured, what is manufacturable, etc. Ability to solve technical problems and address issues through corrective actions Skilled in communicating complicated concepts in a clear, succinct, and simple manner Proactive in asking questions and sharing updates with the team Organized and able to manage multiple projects at once Continuous improvement mindset, e.g., LEAN, Six Sigma Dual language proficiency in English and Spanish 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. PHYSICAL REQUIREMENTS General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs. JOB TITLE: Supplier Quality Engineer JOB SUMMARY Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity supporting projects for the new manufacturing facility in Costa Rica. Assignments include the responsibility for the quality of components and raw materials we receive from suppliers and resolving non-conformance issues that impact the medical devices, also supplier process improvements, reducing costs, and alleviating pain points that negatively affect manufacturing. Duties are assigned to provide experience and familiarization with quality methods, independent thinking, and company practices and policies. ESSENTIAL DUTIES Supports relationships with key suppliers and acts as the Point of Contact for resolution of technical issues and concerns. Works cross-functionally and proactively on supplier quality and management activities, including: Management of injection molding projects including tracking of project scope, schedule, and budget. Area of concentration includes Injection Molding, Thermoforming, and Extrusion for blood-contacting, disposable products Component, process validations (IQ/OQ/PQ), verification and final documentation Engineering Change Requests and Engineering Change Notices for supplier changes Engineering/technical documents such as protocols, reports, specifications, drawings, and vendor provided documents Statistical analysis including process capability, equivalency, and measurement system analysis (i.e. Gage R&R). Supplier quality performance, including corrective and preventive actions Implements and understands FDA or regulatory requirements as necessary Follows technical specification requirements and provides feedback on various technical processes and procedures Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions. Follows department processes and regularly makes recommendations on these processes. Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and responds to questions from technical staff members and management. Works cooperatively and effectively in a team environment or across teams to achieve common goals and results. Analyzes data and presents it in appropriate forums. Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation. OTHER DUTIES AND RESPONSIBILITIES Realize cost reductions and savings by partnering with new, low-cost suppliers. Alleviate pain points and disruptions in the manufacturing process by improving the quality of raw materials and components we receive from suppliers. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor's Degree in Engineering (Mechanical, Industrial, or Biomedical preferred) or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 4 years of experience working with manufacturing processes and a focus on quality. Skills Possesses and applies technical engineering knowledge. Must understand the fundamentals of mechanical engineering, how components are manufactured, what is manufacturable, etc. Ability to solve technical problems and address issues through corrective actions Skilled in communicating complicated concepts in a clear, succinct, and simple manner Proactive in asking questions and sharing updates with the team Organized and able to manage multiple projects at once Continuous improvement mindset, e.g., LEAN, Six Sigma Dual language proficiency in English and Spanish 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. PHYSICAL REQUIREMENTS General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs. JOB TITLE: Supplier Quality Engineer JOB SUMMARY Work requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity supporting projects for the new manufacturing facility in Costa Rica. Assignments include the responsibility for the quality of components and raw materials we receive from suppliers and resolving non-conformance issues that impact the medical devices, also supplier process improvements, reducing costs, and alleviating pain points that negatively affect manufacturing. Duties are assigned to provide experience and familiarization with quality methods, independent thinking, and company practices and policies. ESSENTIAL DUTIES Supports relationships with key suppliers and acts as the Point of Contact for resolution of technical issues and concerns. Works cross-functionally and proactively on supplier quality and management activities, including: Management of injection molding projects including tracking of project scope, schedule, and budget. Area of concentration includes Injection Molding, Thermoforming, and Extrusion for blood-contacting, disposable products Component, process validations (IQ/OQ/PQ), verification and final documentation Engineering Change Requests and Engineering Change Notices for supplier changes Engineering/technical documents such as protocols, reports, specifications, drawings, and vendor provided documents Statistical analysis including process capability, equivalency, and measurement system analysis (i.e. Gage R&R). Supplier quality performance, including corrective and preventive actions Implements and understands FDA or regulatory requirements as necessary Follows technical specification requirements and provides feedback on various technical processes and procedures Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions. Follows department processes and regularly makes recommendations on these processes. Follows technical specification requirements, developing reports, charts, and graphs to support project recommendations and responds to questions from technical staff members and management. Works cooperatively and effectively in a team environment or across teams to achieve common goals and results. Analyzes data and presents it in appropriate forums. Actively participates in Quality System and Good Laboratory Practice requirements, particularly with respect to documentation. OTHER DUTIES AND RESPONSIBILITIES Realize cost reductions and savings by partnering with new, low-cost suppliers. Alleviate pain points and disruptions in the manufacturing process by improving the quality of raw materials and components we receive from suppliers. MINIMUM QUALIFICATION REQUIREMENTS Education Bachelor's Degree in Engineering (Mechanical, Industrial, or Biomedical preferred) or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Experience Minimum 4 years of experience working with manufacturing processes and a focus on quality. Skills Possesses and applies technical engineering knowledge. Must understand the fundamentals of mechanical engineering, how components are manufactured, what is manufacturable, etc. Ability to solve technical problems and address issues through corrective actions Skilled in communicating complicated concepts in a clear, succinct, and simple manner Proactive in asking questions and sharing updates with the team Organized and able to manage multiple projects at once Continuous improvement mindset, e.g., LEAN, Six Sigma Dual language proficiency in English and Spanish 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. PHYSICAL REQUIREMENTS General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment. The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Additional Physical Requirements Requires travel based on business needs. Job Segment: Biomedical Engineering, Manufacturing Engineer, Quality Engineer, Six Sigma, Lean Six Sigma, Engineering, Management