Job Description
Job Title
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Quality Assurance Supplier Engineer II
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\n Job Summary
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\n Supports supplier quality and Quality Engineering by assessing supplier practices and received product, maintaining regulatory compliance, and providing technical guidance for process enhancements. Develops quality standards, controls, product and process qualification and validation documentation, investigates nonconforming product and process failures, and drives supplier quality, efficiency, and productivity improvement
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s.
\n Job Detai
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ls:
\n Main Responsibili
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ties% of
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RoleReview and assess supplier manufacturing practices, procedures, and performance; identify improvement opportunities and drive supplier quality, efficiency, and productivity improvements while maintaining complia
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nce
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.20%Evaluate and test supplier-received product to identify potential failures, recurring manufacturing defects, and other quality risks and ensure product conforms to company standa
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rds
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.15%Identify, report, monitor, and investigate nonconforming events and product or process failures; perform risk and root-cause analyses and implement corrective and preventive actions to prevent recurre
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nce
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.20%Provide quality control support, including product-release authorizations, quarantine of suspect or discrepant product, and timely completion of required nonconformance documentation sta
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ges
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.15%Develop and maintain Quality Instructions, Quality Standards, and quality controls that support compliant supplier, product, and manufacturing activit
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ies
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.10%Support the development, validation, and implementation of test methods and prepare product and process qualification and validation protocols and reports for new products and existing manufacturing li
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nes
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.10%Collaborate with suppliers, management, and cross-functional teams to resolve quality issues, advise on quality assurance requirements, and provide technical guidance on process enhancements and improveme
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nts
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.10%
\n Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at l
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arge.
\n Organizational I
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mpact:
\n Protects product quality, patient safety, manufacturing continuity, and regulatory compliance by ensuring supplier practices and received product meet established requirements. Recommendations and actions affect supplier performance, product disposition, CAPA effectiveness, audit readiness, and process effi
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ciency.
\n Communication & In
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fluence:
\n Works with suppliers, company management, Quality Engineering, Manufacturing, and other cross-functional teams at all organizational levels. Communicates technical findings, nonconformance status, risk assessments, validation requirements, and recommended actions and influences timely resolution of qualit
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y issues.
\n Innovation & C
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omplexity:
\n Addresses supplier, product, process, test-method, validation, and Quality System issues that may involve multiple technical and regulatory factors. Uses statistical methods, engineering judgment, risk assessment, and systematic root-cause analysis to develop compliant and preventive
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solutions.
\n Leadership Autonomy:
\n Independently organizes and executes multiple supplier-quality and Quality Engineering assignments within established procedures. Provides technical input and guidance, recommends improvements, and escalates material product, supplier, compliance, or safety risks. Formal people-management responsibility is n
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ot specified.
\n Organiz
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ational Chart:Reporting relationship and direct/indirect report counts were not provided in the source job description and are to
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be confirmed.
\n Positio
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n Requirements:
\n Knowledge, Skills and A
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- bilities (KSAs):Working knowledge of medical-device Quality System and regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and other standards and regulations affecting
- medical devices.Knowledge of supplier quality, nonconforming-product controls, product release, quarantine, corrective and preventive action, validation, and audit-read
- iness practices.Knowledge of statistical and quality-engineering methods, including design of experiments, statistical process control, Gage R&R, sampling plans, statistics, an
- d data analysis.Strong analytical, mechanical, technical, organizational, leadership, interpersonal, written, and verbal commu
- nication skills.Ability to organize and conduct multiple parallel tasks, compile and analyze data, solve quality problems, motivate others, and imp
- rove efficiency.Ability to work effectively with all organizational levels and contribute as a hands-on, high-energy, team-orient
- ed professional.Computer and software proficiency; SAP know
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ledge is a plus.
\n Backgr
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- ound Experiences:Bachelor’s degree in a technical discipline, such as Mechanical, Biomedical, or Electrical Engineering, or equivalent educatio
- n and experience.Minimum of five years of experience in medical-device q
- uality assurance.Minimum of three years of experience in Manufacturing Engineering or Quality Engineering; validation experie
- nce is preferred.Demonstrated experience handling nonconforming events and supporting investigations, root-cause analysis, and Quality S
- ystem compliance.Six Sigma certifi
- cation is a plus.ASQ Quality Engineer certifi
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cation is a plus.