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Supplier Quality Engineer
2 months ago
The Supplier Quality Engineer II is responsible for all aspects of supplier quality including but not limited to the supplier quality process, supplier non-conformances, supplier change process/notifications, supplier audit, qualification and approval including supplier quality agreements.
•Manage supplier performance and raise potential issues to supplier quality management.
•Support supplier risk assessments and updating the Approved Supplier List.
•Act as lead auditor for supplier quality audits according to the established supplier audit schedule.
•Communicate with suppliers for change notifications and timely follow up actions both internally and externally.
•Support the dispositioning of nonconforming material from suppliers occurs in a timely manner and analyze defect trends, in order to initiate appropriate supplier corrective action.
•Assist suppliers with conducting FMEA, process capability studies and DOE.
•Perform Quality Systems and Process Audits of current and prospective suppliers, including reporting, follow-up and closure of nonconformances.
•Recommend opportunities for cost reduction and quality improvements with suppliers.
•Support Supplier Quality Engineer III to develop and implement improvements to supplier quality policies, processes and procedures.
•Collaborates cross functionally to ensure accurate component specifications are created and implemented as needed.
•Coordinate the approval of new suppliers and communication of status to pending suppliers.
•Support developing and implementing methods and procedures for inspecting, testing and evaluating the precision, reliability and accuracy of supplier products and processes.
•Coordinate with customers and suppliers relating to quality performance, trends and corrective actions.
•Work with suppliers to continuously improve products and processes through lean manufacturing and six-sigma principles and techniques to assure the quality of goods and services provided.
•Support the APQP process in design and process reviews.
•Manage qualification of supplier process change requests inclusive of defining customer requirements as necessary.
•Assess supplier process capability for new components, processes, assemblies and/or purchased finished goods.
This position has no talent management responsibilities.
EDUCATION AND EXPERIENCE
•Bachelor's degree in Engineering or a related field is required.
•4-7+ ears of quality experience in a manufacturing environment or equivalent combination of education and experience is required.
•Minimum 4 years of experience in a Supplier Quality role
•Experience reading and interpreting blueprints and gage design knowledge is required.
•Experience with Lean and Six Sigma methodologies preferred.
•Direct experience leading supplier quality investigations and CAPA activities is required.
•Professional auditing certification by ISO, ASQ or similar preferred.
•In depth knowledge of 21 CFR 820 and ISO 13485 required.
•Strong verbal and written communication skills with all organizational levels as well as excellent interpersonal skills are required.
•Must have exceptional organizational skills, ability to meet deadlines, thrive in a fast-paced environment and be able to problem solve effectively.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
MATHEMATICAL SKILLS
Ability to apply mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical journals and legal documents.Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.Ability to effectively present information to top management and/or boards of directors.
COMPUTER SKILLS
To perform this job successfully, an individual should have knowledge automated inspection software. Proficient with MS Office Suite.
The Supplier Quality Engineer II is expected to:
•Maintain acceptable quality rating for all critical suppliers on an annual basis
•Decrease, through Process and quality systems improvements, customer returns by 10% year over year
•Lead and "pass" all external audits from customers and agencies in a timeframe as defined by the QMS system
•Complete all Supplier CAR according to established procedures (Containment, root cause, corrective action) as defined by Micro QMS
While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk and hear.The employee is occasionally required to stoop, kneel, crouch, or crawl.
The employee must frequently lift, push, pull, carry and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
While performing this Job, the employee is regularly required to demonstrate manual and spatial dexterity sufficient to operate machinery for precision work
While performing the duties of this Job, the employee is regularly exposed to moving mechanical parts and vibration. The employee is frequently exposed to risk of electrical shock. The employee is occasionally exposed to wet and/or humid conditions and odors, dusts, mists, fumes and/or airborne particles.
The noise level in the work environment is usually moderate.
