Keystone Industries · 2 weeks ago
Quality Assurance Assistant
Myerstown, PA
Full-time
Onsite
Entry Level
1+ years expKeystone Industries is committed to creating a supportive workplace and is currently seeking a Quality Assurance Assistant. The role involves assisting the QA Manager and team in maintaining and improving quality systems, including document control, calibration, and customer complaints management.
ManufacturingPackaging ServicesProduct Research
Responsibilities
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
Qualification
Required
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
Company
Keystone Industries
Keystone Industries is a manufacturer of dental and cosmetic products.
201-500 employees
H1B Sponsorship
Keystone Industries has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Irina Rapoport, CPA, CGMA
Chief Financial Officer
Recent News
2026-01-06
GlobeNewswire News Room
2025-07-14
Company data provided by crunchbase