Supplier Quality Associate

Stefanini Group is hiring!

Stefanini is looking for Supplier Quality Associate in Medina NY

For quick Apply please reach out to Vipul Bhardwaj - call:/ email:

Work Hours:M-F (40 hours)

Work Location:Medina NY

Shift:1st Shift

This position has primary responsibility for driving overall quality performance throughout the supply chain.

• Develop and communicate expectations for quality performance continuous improvement quality systems and process controls for both critical sustaining parts and new products.
• As required participate as an active member in the new products development team.
• Perform and coordinate supplier: surveys quality system and process control assessments.
• Work with purchasing to measure and communicate supplier performance on key metrics and the corresponding continuous improvement plans.
• Collaborate with supplier representatives in establishing effective quality systems process controls and problem-solving methodologies.
• Conduct process and component validations as applicable.
• Monitor and drive corrective action and continuous improvement activities that directly impact performance for assigned suppliers.
• Conduct or lead event investigations and root cause analyses relative to purchased materials and components.
• Perform other duties as assigned.

Qualifications and Expertise:

• Bachelors Degree required.
• Lead Auditor training ISO Lead Assessor training with 1-2 years experience in auditing techniques interpreting regulations and quality systems.
• Minimum of 3-5 years of experience in Quality or related field in the medical products industry.
• Knowledge & application of reading and understanding blueprints/technical drawings.
• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Experience in manufacturing/quality assurance engineering in an FDA regulated environment.
• Knowledge and working application of standard operating procedures.
• Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
• Knowledge and working application of data entry and spreadsheet applications.
• Computer competency in Word Excel Power Point Minitab Access and databases.
• Practical experience in metrology test equipment inspection and analysis techniques.
• Desired experience is in the medical device industry development and deployment of Quality System and process controls and continuous improvement methods (QSR ISO13485).
• Desired CQE CSSBB CQA or initiative to complete certifications.
• Primary/Secondary party compliance auditing experience.
• Ability to multi-task and methodically manage projects.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Effectively operate in and facilitate cross-functional teams with guidance.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• Ability to: stand or walk for long periods lift and carry at least 20 pounds perform repetitive motions with hands/fingers.
• Demonstrated strong analytical problem solving (CAPA) teaming and communications/interpersonal skills.
• Must be willing to travel as needed.

Physical Demands:

Able to exert up to 10 pounds of force occasionally. Able to sit stand and walk throughout the workday.

Work Environment:

• Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• This is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
• Wearing a static protective smock at all times while in the manufacturing work area.
• Working in close proximity to other employees.
• Working in an environment that is temperature and humidity controlled.
  
  

Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.

About Stefanini Group

The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.

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