Supplier Quality Management Job Description
Supplier quality management
provides regulatory expertise to lead and support Align Technology Inc.’s MDSAP-certified Quality System efforts globally based on FDA QSR, ISO 13485, EU Medical Device Regulation, Canadian Medical Device requirements, Japan’s Pharmaceutical Affairs Law (JPAL) and any other applicable worldwide regulatory requirements and business needs (HIPAA).
Supplier Quality Management Duties & Responsibilities
To write an effective supplier quality management job description, begin by listing detailed duties, responsibilities and expectations. We have included supplier quality management job description templates that you can modify and use.
Sample responsibilities for this position include:
As a team leader, participate and coordinate with the engineering and procurement activities to identify strategic suppliers and their associated risks, including facilitation of systemic techniques and quantitative analysis
Assist in the identification of significant variables and develop/author supplier quality control plans
Drive proactive continuous improvement efforts in quality performance.
Lead the execution of supplier development and quality control plans
Ensure metrics for supplier quality are developed, maintained and reviewed to promote continued and/or sustained success
Interfaces with Customer on supplier issues, as required
Conceives, proposes, and sells new ideas, strategies, or concepts, and guides those projects to completion
Makes and takes responsibility for decisions that have wide-impact
Drive discussion across the organization and consider the implications of their work within the scope of the company
Oversee the planning process and delegation across teams and/or departments
Supplier Quality Management Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Supplier Quality Management
List any licenses or certifications required by the position: VDA6.3, ASQ, CQE, MSD, VDA
Education for Supplier Quality Management
Typically a job would require a certain level of education.
Employers hiring for the supplier quality management job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Management, Technical, Mechanical Engineering, Business, Biological Sciences, Education, Chemistry, Manufacturing
Skills for Supplier Quality Management
Desired skills for supplier quality management include:
Ability to apply GMP in conformance to US
EU and ROW standards
FMEA
Regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system
SPC
Standards
Six Sigma
FDA QSR and MDSAP
ISO 13485
Desired experience for supplier quality management includes:
Minimum of 3 year experience in advanced industries like automotive, pharmaceutical, aerospace
Respectful manners and superior behavior
Accurate and conscientious operation, keen understanding of quality
Work self-engaged after familiarization phase and willingness to learn
Quality training auditor
NDT non-destructive testing (ISO 9712 PT, MT, VT Level 2) optional
Supplier Quality Management Examples
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Supplier Quality Management Job Description
Job Description Example
Our company is growing rapidly and is looking for a supplier quality management. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for supplier quality management
- Engage with (or may lead) global quality networks the business unit and associates toward the effective promotion and alignment of organizational goals to the company’s mission and vision
- Perceived as thought leader possessing subject matter expert knowledge of global regulations
- Significantly contribute to development of local and/or global strategiesAccomplishes tasks through highly experienced professional specialists or manager
- Oversee and coordinate the global supplier audit program and annual supplier audit plan, including suppliers incorporated though acquisition activity
- Work with business, regional, and plant quality representatives to drive supplier management programs across the globe
- Develop and coordinate the use of a database for the management and tracking of supplier information
- Develop and implement appropriate reporting metrics, structure and schedule -- Review and maintain supplier quality metrics for management review
- Provide operational due diligence assistance in the assessment (operational management, technology, product and process), certification, and performance improvements of suppliers
- Own corporate level procedures for company-wide supplier management processes
- Support a Genentech Biologic Drug Product site
Qualifications for supplier quality management
- Detailed understanding and application of current Good Manufacturing Practices and Agency compliance expectations
- Typically requires a bachelor's or master's degree in engineering or related discipline and ten or more years of related experience with a bachelor's degree or eight or more years with a master's degree
- Must have a demonstrated ability to convey complex technical information clearly to individuals with varying degrees of expertise
- Must be a strong team leader who works effectively with others, have excellent communication skills (written and verbal), and have strong technical skills
- Sound understanding of AS9100/ISO9001 QMS standard
- Experience with Software Quality, spares and Engineering change management in the field is a plus
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Supplier Quality Management Job Description
Job Description Example
Our growing company is looking for a supplier quality management. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for supplier quality management
- Experience the challenges of communicating and coordinating with globally-located external third parties (direct material suppliers)
- Experience working with a global team while driving improved quality processes at the site-level
- Responsible and accountable for planning, leading, executing and post-processing of supplier IMS audits
- Complete audit reports and communicate with suppliers within the time frame per internal procedures and ensure that all audit findings are effectively contained and communicated to suppliers and internal partners
- Identify and communicate issues that could impact product quality, system gaps or business continuity and ensure that these issues are effectively and promptly contained and addressed
- Maintain supplier quality management system audit files and ensure that records are filed on time per procedure requirement and are compliant with defined requirements
- You will work closely with the SQM Category teams in order to continuously improve product quality, delivery and systems at the supplier base
- Develop/modify the audit process, procedures and audit checklist as regulatory requirements change or as a result of continuous audit process improvement
- Facilitate training of colleagues
- Create and foster a strong working relationship with the different Global Supplier Quality functions, Strategic Sourcing and additional key interfaces to facilitate effective collaboration
Qualifications for supplier quality management
- A Degree in electronics, electro-mechanical Engineering or equivalent
- Candidate preferably should possess knowledge in quality, and product and component reliability
- Experience in product safety and environment certification, notably China specific certification processes (CCC) would be a plus
- BS/BA degree in science or engineering required
- Lean 6 Sigma knowledge yellow or green belt level required
- Intermediate proficiency in use and knowledge of computer systems, applications and databases (i.e., MS Word/Excel/Access preferred) required
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Supplier Quality Management Job Description
Job Description Example
Our company is growing rapidly and is hiring for a supplier quality management. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for supplier quality management
- Provide final direct material disposition recommendations that may be affected by deviations or discrepancies
- Lead and participate in the design and implementation of department and cross-functional initiatives
- Support multiple Genentech Biologic Drug Substance sites
- Initiate vendor changes and manage supplier related discrepancies for SQM Americas
- Lead the supplier management activities associated with the Business Unit, with a focus on onboarding suppliers, supplier audits, and management of supplier corrective actions (SCARS)
- Supporting the CAPA program for the Business by participating in the CAPA review board to present SCAR metrics, and owning CAPAs, where appropriate
- Oversee supplier audit process, including scheduling, conducting, and reporting
- Participate and collaborate with employees in a global company to ensure QMS compliance and align local SOP’s as required with common Business Unit SOP’s
- Be a leader in introducing and coordinating improvements through training, coaching, new quality tool implementation, and authoring or editing standard operating procedures
- Guides and/or mediates the decision making process on project and deliverable execution
Qualifications for supplier quality management
- Bachelor’s in Electronics, mechanical, chemical, power management or manufacturing preferred
- Minimum 8 years’ experience in a manufacturing or design environment
- 5+ years working experience in Li battery cell or pack design, manufacture or process management
- Minimum 15 years’ experience with 10 years in a manufacturing and/or quality environment
- Expert with relevant commodity manufacturers on Quality and Process improvement projects
- Translate Quality Systems strategy into tactical plans and drive implementation
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Supplier Quality Management Job Description
Job Description Example
Our company is hiring for a supplier quality management. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for supplier quality management
- Identifies and manages areas of potential noncompliance
- Lead, develop and manage the SQM team to assure compliance of the SQM elements
- Direct Purchasing Contracts and Purchase Orders
- Indirect Purchasing Processes and Systems
- Supplier Quality Methods and Reporting
- Purchasing-related Business Intelligence
- Resolving supplier process/system issues through via a Supplier Advocate Team
- Develop, plan, and conduct audits
- Leads the development of a strong partnership with external suppliers and ICUMedical Manufacturing operations
- Management of API/Excipient manufacturing, Container Closures, Packaging, Labeling and other suppliers
Qualifications for supplier quality management
- Working knowledge of problem solving techniques and statistics
- Working knowledge of statistical tools using Minitab for cause analysis and statistical decision making
- Hiring, developing, Coaching, Mentoring experience
- Master or above Degree in Engineering or similar discipline
- Product Reliability issue and analysis experience would be a plus
- Strong interpersonal skills required to interact with and influence senior level management across the organization
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Supplier Quality Management Job Description
Job Description Example
Our company is searching for experienced candidates for the position of supplier quality management. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for supplier quality management
- Corroboratively review performance data with suppliers to develop action plans for performance enhancement
- Ensure supplier metrics and KPIs optimize the ICUMedical-supplier relationship
- Manage up to 7 Supplier Quality Employees, including Program Managers and Auditors in Solutions/API/Excipients Field
- Assure that proposed changes to the supplier processes or supply base are approved and compliant to ICUMedical procedures
- Be the Quality Authority in the process for the selection, development, and approval of new Solutions suppliers and assure that strategic initiatives are met
- Scheduling audits, maintaining accurate information and updates to the supplier schedule, and tracking and reporting metrics associated with completion and execution of audit activities for Device Suppliers and TPMs
- Audit preparation and agenda communication
- Scheduling audits with suppliers
- Audit report creation and finalization
- Issuing approved audit reports to supplier
Qualifications for supplier quality management
- Strong related commodity's process quality improvement and product qualification background preferred
- Auditor certification by third party
- 8+ years in quality, compliance, and regulatory experience in the medical device industry
- 6+ years in managing Global Supplier Quality Management Program in the medical device or pharmaceutical industry
- Experience in technical or manufacturing operations
- Demonstrated ability to streamline organization to maximize efficiencies to resolve discrepancies and trending issues