Supplier Quality Associate-AS-R2 Position Available In Orleans, New York

Supplier Quality Associate-AS-R2 3.3 3.3 out of 5 stars Medina, NY 14103

Job Title:

Quality Associate II Location:

Medina, NY,14103

Duration:

7-month contract with a possibility of extension

Shift Details :

Shift 1

Pay Range:

$41/hr – $43/hr

Job Description :

I. Summary Responsible for driving quality performance throughout the supply chain. Supports both critical sustaining parts and new product development initiatives. II. Essential Functions Develop and communicate quality performance expectations and continuous improvement goals. Support new product development teams as needed. Conduct supplier surveys, quality system, and process control assessments. Collaborate with purchasing to track and report supplier performance metrics. Drive continuous improvement plans based on supplier performance data. Partner with suppliers to implement quality systems and effective process controls. Conduct validations of processes and components as necessary. Monitor corrective actions and lead continuous improvement initiatives for assigned suppliers. Investigate quality events and perform root cause analyses for purchased components/materials. Perform other related duties as assigned. III.

Qualifications, Knowledge, and Skills Technical & Industry Knowledge:

Ability to read and interpret blueprints/technical drawings. Understanding of quality assurance and manufacturing engineering practices in FDA-regulated environments. Familiarity with FDA c

GMP, ANSI/ISO/ASQC, CMDAS

requirements. Experience with quality systems, SOPs, process controls, and continuous improvement. Knowledge of medical device industry regulations (QSR, ISO13485 preferred).

Tools & Technology:

Proficiency in Microsoft Word, Excel, PowerPoint, Access, and Minitab. Experience with metrology, inspection techniques, and test equipment. Competency in data entry and spreadsheet/database applications. Certifications (Preferred): CQE (Certified Quality Engineer) CSSBB (Certified Six Sigma Black Belt) CQA (Certified Quality Auditor) Willingness to pursue relevant certifications.

Auditing:

Experience with primary/secondary party compliance auditing. Lead Auditor or ISO Lead Assessor training preferred.

Soft Skills:

Strong analytical and problem-solving skills (CAPA). Ability to manage multiple tasks and projects efficiently. Effective written and verbal communication. Team collaboration and cross-functional facilitation skills. Ability to influence decisions with minimal supervision. IV.

Education & Experience Required:

Bachelor’s Degree.

Experience:

3-5 years in Quality or related field, preferably in the medical products industry.

Auditing:

1-2 years of experience with auditing techniques and interpreting regulations. V. Physical Demands Ability to stand or walk for long periods. Capable of lifting and carrying up to 20 pounds. Perform repetitive hand/finger motions. VI. Work Environment FDA-regulated manufacturing setting with strict compliance standards. Environment is temperature- and humidity-controlled.

Must follow work rules including:

Wearing static-protective smocks in designated areas. Working in close proximity with other employees. #IND2

Job Types:

Contract, Temporary Pay:

$41.00 – $43.00 per hour Expected hours: 40 per week

Benefits:

401(k) Dental insurance Health insurance Referral program Vision insurance

Schedule:

8 hour shift Day shift Monday to Friday Application Question(s): Are you a US Citizen or GCH? If on Visa please mention the Visa Status Are you ready for background check and drug screen in accordance with the local law and regulations? Please confirm your email address and contact number? Cube Hub payroll is “Bi-Weekly, we pay every-other-Friday. Are you Comfortable with Bi-Weekly payroll policy? What is your Expected Pay Range? Are you ok with following Shift-1? What is a good time to contact you? Have you completed Lead Auditor or ISO Lead Assessor training? Experience with quality systems, SOPs, process controls, and continuous improvement.? Familiarity with FDA c

GMP, ANSI/ISO/ASQC, CMDAS

requirements?

Education:

Bachelor’s (Preferred)

Experience:

Quality and preferably in the medical products industry.: 3 years (Required) auditing techniques and interpreting regulations.: 1 year (Required)

License/Certification:

Do you hold a CQE, CQA, or CSSBB certification? (Required)

Work Location:

In person