QA-Supplier Job Description
Qa-supplier
provides feedback to the audited departments and upper management on compliance to GMP (QSR) Regulations (21 CFR Part 820; 210; 211 &1271), FDA Aseptic Processing Guidance, ISO 13408, 9001, 13485 standards, and European Union Medical Directives.
QA-Supplier Duties & Responsibilities
To write an effective qa-supplier job description, begin by listing detailed duties, responsibilities and expectations. We have included qa-supplier job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure quality support activities and products are in compliance with both Sony and customer quality assurance standards, ISO/TS16949 and applicable government regulations
Maintain Vendor files and conduct periodic assessment of files to ensure all certification documents, licenses, and statements are current and comply with current regulations and standards
Applying technical quality assurance protocols and methods to monitor production and field quality finished products
Performs data analysis and identifies failure trends of finished products
Recommends corrective actions when necessary
Ensure products strictly adhere to established manufacturing quality inspections and statistical process control procedures are followed
Ensures the Supplier Quality function operates according to procedures and provides direction to other departments
Collaborates with the Procurement team assigned to support supplied products and materials
Plan and execute supplier audits, as part of supplier capability assessments
Reviews and assesses deviations
QA-Supplier Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QA-Supplier
List any licenses or certifications required by the position: ASQ, HACCP, SQF, AWS, CQA, CQM, DMAIC, GFSI
Education for QA-Supplier
Typically a job would require a certain level of education.
Employers hiring for the qa-supplier job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Technical, Science, Education, Manufacturing, Medical, Biology, Chemistry, Management, Life Science
Skills for QA-Supplier
Desired skills for qa-supplier include:
Standards
FDA legislation
Global complaint handling requirements within medical devices/IVDs
ISO 13485
IVD/IVDR
MDSAP
Regulatory demands and standards: MDD/MDR
Regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system
21 CFR 210
Desired experience for qa-supplier includes:
Be engaged in work and invest time, passion and best efforts to accomplish goals
Persist in achieving goals in spite of barriers or obstacles through personal commitment to work
Able to travel up to 40% domestic
Higher technical education (preferably in Mechanical Engineering)
Mastery (C2) or at least Effective Operational Proficiency (C1) in German and English
Effective Operational Proficiency (C1) or at least Upper Intermediate (B2) in French
QA-Supplier Examples
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QA-Supplier Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of qa-supplier. 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 qa-supplier
- Leads and facilitates failure investigations
- Draft SOPs for Supplier selection, management and qualification of all external vendors, contract manufacturing organizations (CMO’s), contract research organizations (CRO’s) and service providers (i.e., maintenance, calibration and test laboratories)
- Develop a supplier audit schedule, generate audit plans and conduct quality audits for GMP suppliers, CMO, and service providers
- Negotiate and draft quality agreements with all critical suppliers, CMO’s and service providers
- Manage product quality complaints, quality incidents and CAPA associated with materials and/or services provided by our suppliers and initiate Supplier Corrective Action
- Maintain the Approved Vendor list for Intarcia
- Participate in the Material Specification Committee Board to review and approve Material Specifications
- Maintain Supplier vigilance including KPI’s to ensure the suitability of materials for compliance with specifications and regulations
- Maintain Vendor audit reports, audit responses, and pertinent corrective actions, follow-up for audits conducted in support of the supplier qualification program
- Create key quality metrics for tracking and trending data related to supplier audits, agreements, supplier incidents, and report metrics including significant quality incidents to QA management
Qualifications for qa-supplier
- Focus on highest priority actions first
- Take action in daily work to positively impact people, communities and the environment
- Foundry knowledge for valve castings preferred
- Knowledge in risk management documentation
- Knowledge in investigation process
- Executes procedures of moderate complexity with high quality
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QA-Supplier Job Description
Job Description Example
Our company is growing rapidly and is looking for a qa-supplier. 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 qa-supplier
- Presenting Intarcia’s supplier qualification program to regulatory agencies and interacting with regulatory agencies during inspections on supplier QA related matters
- Manage other QA responsibilities to support GCP and GMP functions, as assigned by the Supervisor
- Participates in all leadership activities as the representative for the QA/RA function
- Provides leadership for the Batesville QA/RA Supplier Quality organization
- Develops and deploys supplier quality systems strategy for Batesville facility
- Executes supplier controls processes for conducting supplier qualification, purchased part qualification, and supplier monitoring & re-evaluation for Batesville facility
- Drives overall supplier quality performance
- Implements supplier development initiatives, when necessary, to improve supplier performance
- Coordinates and performs supplier audits, as needed
- Ensures appropriate controls (key metrics) are defined, implemented and satisfactorily completed for all suppliers
Qualifications for qa-supplier
- Excellent communication, interpersonal skills organizational skills and attention to detail
- Demonstrated experience with data analysis, value stream mapping, 6‐Sigma, and Kaizen events preferred
- Experience with statistical analysis packages such as JMP and Minitab is a plus
- Quality Certification preferred (e.g., CQE)
- Applied experience with quality and statistical analysis tools
- Must have a valid driver’s license in good standing and the ability to travel abroad
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QA-Supplier Job Description
Job Description Example
Our innovative and growing company is hiring for a qa-supplier. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for qa-supplier
- Provides training resources to ensure proper implementation and use of quality tools and procedures as required
- Perform direct and indirect supplier evaluation and selection activities, including supplier capability assessments and supplier quality systems/manufacturing process audits
- Execute contracts and Quality Plans with Suppliers to ensure quality requirements are met
- Develop, implement, and monitor early supplier quality development initiatives, including supplier performance management, supplier certification, process improvements, cost reduction, supplier forums and Six Sigma/Lean integration
- Lead supplier new part qualification activities, including development of capability studies, control plans, first article inspections, PFMEAs, Review and approve engineering design changes and supplier change requests to determine part re-qualification needs
- Must be willing and flexible for business travel as required (supplier audits)
- Participates as an active member in the New Product Development process supplier evaluation team and the sourcing core team
- Collaborates, trains, and mentors supplier representatives in best practices such as quality systems, process controls methods, problem solving and statistical tools
- Monitors and drives corrective action and continuous improvement activities that directly impact performance for assigned suppliers
- Follow up supplier nonconformance material to proper disposition and implementation of actions to resolve nonconformances at supplier facility
Qualifications for qa-supplier
- Experienced and certified quality auditor with proven track record in negotiating quality agreements, hosting internal audits and conducting various types of supplier audits (i.e., raw material suppliers, contract manufacturing organizations and Service providers )
- Proven track record and experience in representing supplier qualification program to the global regulatory agencies
- Hands on execution of all aspects of supplier quality assurance functions in in an entrepreneurial, fast paced environment
- Awareness of 8D Problem solving, Quality tools like 5 Why, Fishbone Diagram, FMEA
- A total combined 7+ years industry and/or regulatory/compliance including some supervisory or management experience
- Demonstrated leadership and technical skills in supplier management, supplier assurance or control
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QA-Supplier Job Description
Job Description Example
Our innovative and growing company is hiring for a qa-supplier. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for qa-supplier
- Participate & provide solution while handling in Engineering Trouble Shooting and Operation support in region or India
- Participate in data analysis to improve the performance/productivity
- Applies modern principles of quality assurance to product, process and quality strategic planning, validation and improvement
- Applies the appropriate tools of quality technology during product design, development and manufacture
- Establishes and performs to measures that monitor Key Performance Indicators (KPI’s) related to divisional Quality Attainment
- With the VP, QA, conceptualizes and validates strategic supplier quality direction
- Works through issues with each Supplier, strategically utilizing resources within the functional group and the business as needed
- Maintenance of documentation in accordance with GMP including timely recording of information
- On-site support of contract manufacturing as needed
- Generates disposition documentation and ancillary contract manufacturer documentation needed for final product disposition
Qualifications for qa-supplier
- Ability to provide technical expertise, consultation and recommendations to suppliers to improve product performance and QA principles
- Ability to interact at all levels of the organisation with proven influencing and negotiation ability
- 5+ years of experience in Quality Assurance or Regulatory Affairs, medical device experience preferred
- Successful record of managing people and projects
- 3+ years leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence)
- Proven ability to resolve supplier related issues to meet production schedules
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QA-Supplier Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of qa-supplier. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for qa-supplier
- Write, revise or review SOPs, Specifications and other GMP documentation
- Interaction with both internal and external plant personnel to ensure cGMP compliance and continuous improvement
- Responsible for effectively managing interactions and inspections for the global audit program by external regulatory agencies, internal auditing and customer audits
- Partner with R&D Process Development, Purchasing, R&D Quality Assurance and Business Development to ensure that supplier selection will meet the manufacturing site needs
- Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments
- Perform analysis and report actual costs, budget variance analysis, development of Estimate at Complete (EAC), and support the Functions' monthly financial and business rhythm
- Communication of budget performance and risk assessment/analysis
- Serve as the Liaison for SQM Intra Work Transfer Agreement (IWTA) and monitor performance until contract closure
- Production and Sustainment Basis of Estimates (BOE), Statement of Work (SOW) and Contract Review
- Manage Suppliers and Service Providers Qualification System
Qualifications for qa-supplier
- Ability to identify deviations from established procedures with consultation from supervisor
- A minimum of 10 years’ experience with extensive knowledge and experience in managing supplier quality assurance groups in highly regulated pharmaceutical environments
- Supplier auditing experience preferred
- Track record of business and customer orientation
- Quality Management (CQM) and/or Quality Auditor (CQA) certification preferred
- Bachelors of Science in Engineering or other related technical field (Preferably concentrated in Mechanical, Industrial)