Quality Associate II

Immediate need for a talented Quality Associate II. This is a 06+months contract opportunity with long-term potential and is located in Medina, NY (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-75312

Pay Range: $40 - $46/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan.

Key Responsibilities:

• 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.
• PHYSICAL DEMANDS
• Able to exert up to 10 pounds of force occasionally. Able to sit, stand, 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.
• 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.
• Perform other duties as assigned.

Key Requirements and Technology Experience:

• Key skills; Quality Associate, FDA, Audit
• 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.
• Bachelor s 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.

Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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