Quality Assurance Assistant

Company Overview At Keystone Industries, we believe that people drive our success. We're committed to creating a workplace where employees feel respected, supported, and inspired to grow their careers. From manufacturing to innovation, we thrive on collaboration, continuous improvement, and shared achievement. In addition to competitive compensation, we offer a wide range of benefits and programs to help our employees thrive

• both professionally and personally. Join the Keystone team
• where your contributions matter, and your career can grow with us.

To learn more about our company and open opportunities, please visit: www.keystoneind.com Keystone Industries is currently seeking a Quality Assurance Assistant for our Myerstown, PA location.

Position Title:

Quality Assurance Assistant Shift M-Th, 8:00 AM

• 4:30 PM; F, 7:00 AM
• 3:30

PM Position Overview:

Provide assistance and support to the Manager of QA and other QA team members in the maintenance and improvement to the quality system, which may include the following: Maintenance of the Document Control System including: Drafting procedures, work instructions, Forms, technical documents and quality system reports. Maintenance of the system to ensure only valid documents are utilized. Processing reviews and approvals of document changes. Maintain current revision and distribution of product drawings. Prepare, update, and maintain product information/technical files. Coordinate with supervisors to maintain current employee training records.

Maintenance of Calibration System:

Review calibration records to ensure measurement equipment is maintained with current calibration. Coordination with external suppliers as applicable for the performance of recalibration activities. Maintain the Corrective/Preventive Action system including the CAR/PAR log and files. Perform follow-up verification activities of all CAR/PARs issued and ensure closeout is timely and effective. Maintain records of product non-conformances and follow-up with the appropriate individuals to ensure proper completion/resolution to the problem. Maintenance of the Customer Complaints received in Myerstown. Communication with involved parties to ensure customer satisfaction and resolution to their complaint issue. Completion of investigational activities to ensure issue is resolved and closed. Reporting complaint trends to the Manager of QA/RA. Perform internal audits Maintain Labeling Control through verification against master artwork; updating the hard copy and electronic labeling files.

Product Release Activities:

perform release of manufactured and packaged product, assure good documentation practices are utilized throughout the processes. Performance of product release testing as applicable Generate product Declarations of Conformity as requested by customers Documentation and Coordination with R&D/Maintenance Personnel to validate/verify new or moved equipment used in manufacturing medical devices. Assist the QA Manager with other tasks as needed.

Skills and Qualifications:

Minimum 1-year Quality Assurance or related experience in an ISO/FDA regulated Facility. Must Possess excellent written and oral communication skills with a strong attention to detail. Good problem-solving skills Multi-tasking skills-must be able to handle and prioritize several tasks Knowledge and experience with internal auditing. Must have working knowledge of Microsoft Office applications (Word, Excel, Outlook, etc.) Must be familiar with Quality Management Systems required to maintain compliance to regulatory standards of the

US FDA, ISO

13485, Health Canada, EU MD requirements, etc.

Benefits:

Weekly Pay Enriched Medical, Dental, and Vision Plans Flexible Spending Accounts (FSA)

• Medical & Dependent Care or Health Savings Account (HSA) Options 401(k) Retirement Savings Plan with Safe Harbor
• Employer Contribution of 3% of Gross Wages Tuition Assistance Program Company-Provided Term Life Insurance Voluntary Insurance Options
• Term Life, Accident, Disability, Critical Illness, and Hospital Indemnity Paid Time Off (PTO)
• Accrued time off to support work-life balance Paid Holidays Employee Assistance Program (EAP)
• Confidential employee support services Financial Wellness Resources Employee Discounts & Perks
• Depending on available programs