Quality Auditor Position Available In Orleans, New York

Quality Auditor 3.7 3.7 out of 5 stars Medina, NY 14103

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.

Qualifications and Expertise:

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. 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.

Job Type:

Contract Pay:

$35.00 – $39.00 per hour Expected hours: 40 per week

Schedule:

8 hour shift

Work Location:

In person