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Quality Assurance Assistant Location
Myerstown, PA Shift & Schedule
MTh, 8:00 AM 4:30 PM; F, 7:00 AM 3:30 PM Position Overview Maintenance of the Document Control System, including drafting procedures, work instructions, forms, technical documents, and quality system reports. Ensure only valid documents are in use, process reviews and approvals of document changes, and 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. Maintain the Calibration System: review calibration records to ensure measurement equipment is current; coordinate with external suppliers for 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 timely closeout. Maintain records of product non?conformances and follow up with appropriate individuals to ensure resolution. Maintain the Customer Complaints system for Myerstown, communicate with involved parties, conduct investigational activities, report complaint trends to the Manager of QA/RA. Perform internal audits. Maintain Labeling Control by verifying against master artwork and updating hard?copy and electronic labeling files. Product Release Activities: perform release of manufactured and packaged product, ensuring good documentation practices throughout the processes. Perform product release testing as applicable. Generate product Declarations of Conformity as requested by customers. Document and coordinate 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. Excellent written and oral communication skills with strong attention to detail and good problem?solving skills. Multi?tasking skills; must be able to handle and prioritize several tasks. Knowledge and experience with internal auditing. Working knowledge of Microsoft Office applications (Word, Excel, Outlook, etc.). Familiarity with Quality Management Systems required to maintain compliance with 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
Company Overview
At Keystone Industries, we believe that people drive our success. Were 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. Equal Opportunity Employer
Equal Opportunity Employer. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor. Referrals increase your chances of interviewing at Keystone Industries by 2x. Get notified about new Quality Assurance Assistant jobs in
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Sprachkenntnisse
- English
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