Quality Manager – Pittsburg, PA
BeamOne LLC is currently seeking a Quality Manager to join our dynamic team. The successful candidates will be able to the following:
SUMMARY
Assure compliance to the company’s Quality System at the Saxonburg (Pittsburg, PA) site. Oversee quality assurance and regulatory affairs matters. The ideal candidate will be well versed in the FDA Quality System Regulation (QSR) pertaining to the medical device industry, and the ISO 13485 quality system requirements. Experience with radiation sterilization processing and validation (ISO 11137) is preferred, but no required.DUTIES AND RESPONSIBILITIES include the following:
Act as deputy management representative for the site.
Oversee QA matters for the facility and provide quality improvement recommendations as well as corrective and preventive action as appropriate.
Ensure production records are reviewed for accuracy and compliance with company procedures and regulatory requirements.
Oversee the review and release of production lots by quality assurance personnel.
Ensure the document control system is in compliance with company procedures, and regulatory requirements.
Ensure that site personnel are trained to the procedures appropriate to their job description.
Ensure that product and process deviations are properly documented and investigated in a timely manner.
Oversee the customer complaint system to ensure accurate documentation, corrective action, and timely response.
Perform internal and external quality audits.
Facilitate and implement facility management review.
Experience conducting and/or documenting process validation activities are preferred.
Experience with radiation processing of medical devices and/or sterilization validation of medical devices is preferred.EDUCATION AND/OR EXPERIENCE
Bachelors of Science specializing in microbiology or biology, and three to ten years of related experience and/or training in a FDA registered company; or equivalent combination of education and experience. Working knowledge of FDA medical/pharmaceutical quality system requirements, and 13485. Experience in quality auditing is also required.If you are interested in exploring an opportunity with our dynamic company please submit your resume to jsigliano52@gmail.com
Production Manager – Pittsburg, PA
BeamOne LLC, an electron beam medical device and pharmaceutical sterilization service center is currently seeking a Production Manager to join our dynamic team in the Pittsburg, PA area. The successful candidate will be able to do the following:
Manage the flow of product within the BeamOne service center, including product scheduling, shipping and receiving, and processing and releasing of product according to BeamOne Quality System.
Oversee and schedule personnel and manage employee performance, safety, and security. Act as a facility representative for production staff to visitors.
Perform operation of LINAC and conveyor control systems. Supervise processing of product to FDA regulated specifications.
Supervise shipping and receiving of product, documenting that product meets specific required information and verifying box count, lot number and any product damage.
Assist Quality Assurance Manager in the development, implementation and conformance of quality practices and continuous improvement processes.
Assist and work in concert with Testing Services Technician, Customer Service and Maintenance staffs to ensure operational efficiencies and a high level of customer satisfaction are met.
Interview and hire production personnel as needed.
Oversee training of production personnel in Quality Manual, SPSA, SOP and safety procedures.SUPERVISORY RESPONSIBILITIES
This position is responsible to supervisor lead operators for a three shift 24/7 operation.EDUCATION AND/OR EXPERIENCE
Two to five years experience as production manager for FDA registered companies. Experience in shipping and receiving and safety issues. Bachelor’s Degree preferred but not required.OTHER ESSENTIALS
Basic mathematical skills with the ability to analyze and solve problems. Organized with strong attention to detail. Good communication skills. Forklift certified.If you are interested in exploring an opportunity with a growing company please submit your resume to jsigliano52@gmail.com.
Maintenance Technician – Pittsburg, PA
BeamOne LLC, an electron beam medical device and pharmaceutical sterilization service center is currently seeking a Maintenance Technician to join our dynamic team in the Pittsburg, PA area. The successful candidates will be able to do the following:
SUMMARY
Perform and supervise service center maintenance activities in accordance with the BeamOne Quality System. Responsible for tracking all maintenance activities using a work order system created in BigFoot. Perform repairs and maintenance on a mechanical conveyor system and S-Band Modulator / Linear Accelerator.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Perform and supervise all service center maintenance activities.
Responsible for tracking all maintenance activities using a work order system created in BigFoot.
Perform repairs and maintenance on a mechanical conveyor system and a complex electronic system.
Troubleshoot low voltage circuit boards, control systems, and high voltage components.
Remedies system malfunctions.
Troubleshoots PLC code as required to determine cause of system faults.
Follow electrical schematics during troubleshooting.
Maintains a spare parts inventory for the LINAC and conveyor system.
Provides support in purchasing and inventory control of spare parts.EDUCATION AND/OR EXPERIENCE
Minimum two years of college and three years of related experience and/or training or equivalent combination of education and experience. Knowledge of and ability to use practical electronic theory, basic machine tools and to work from schematics and rough sketches. Must have a working knowledge of computers for industrial controls (PLCs). Able to read PLC code (ladder logic) for troubleshooting system problems. Must have a general understanding of basic electronics. Must have good troubleshooting skills.OPTIONAL QUALIFICATIONS
Experience with high voltage and/or pulsed power
Experience with RF
Experience with UHV (ultra high vacuum) systems
Experience with Allen Bradley PLCs (PLC5, ControlLogix)LANGUAGE SKILLS
Ability to read and write.MATHEMATICAL SKILLS
Advanced mathematical skills.If you are interested in joining our dynamic company please submit your resume to jsigliano52@gmail.com.