USA - Quality Associate II

I. SUMMARY:
This document outlines the employment prerequisites and job responsibilities for the Supplier Quality Associate II position.

II. ESSENTIAL FUNCTIONS:
This position has primary responsibility for driving overall quality performance throughout the supply chain.
Specific responsibilities include:
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.

III. QUALIFICATIONS KNOWLEDGE AND SKILLS REQUIRED

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.

IV. EDUCATION/EXPERIENCE REQUIRED
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.

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

VI. 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.
Client 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.