Quality Assurance & Control Associate

Consolidated Sterilizer Systems (CSS) is a long-standing leader in the manufacturing of laboratory steam sterilizers (autoclaves) for the best universities, biotech, and pharma companies around the world. We are expanding into the Medical Device market and we are seeking a Quality Assurance & Quality Control Associate responsible for ensuring that all products designed and produced at the site meet or exceed customer requirements, specifications and expectations for Quality.

Responsibilities:

• Oversee the Quality Management System at CSS.
• Perform internal audits and coordinate external audits.
• Develop and revise procedures such as work instructions, QC checklists, forms, etc. as required to maintain compliance and improve quality performance.
• Perform inspection of purchased parts, assemblies, and materials, and first article inspections.
• Final inspection of in-house manufactured products prior to outgoing shipment
• Perform system level & in-process inspections of manufactured goods as required
• Document inspection results by completing reports and logs, summarizing rework and waste, recording data in compliance with requirements
• Manage the nonconforming material process. Coordinate to determine disposition of non-conforming items. Record inspection and disposition information.
• Manage the corrective and preventative action process (CAPA).
• Manage the complaints handling system.
• Assist with supplier qualification and vendor audits as required.
• Interface with vendors to resolve quality issues as required
• Ensure maintenance all quality records. Maintain compliance with document control system.
• Work with engineering to ensure quality assurance of new products, and the development of procedures and processes to meet quality requirements.
• Assist with maintaining the calibration system, ensuring measuring & inspection devices are in compliance.
• Establish tools to monitor quality processes and prepare reports of findings on a regular periodic basis and present at management review meetings.
• Work with production employees to resolve manufacturing issues.
• Maintain a clean and safe work environment.
• Perform other duties as assigned to support the advancement of quality systems and operations.

Requirements:

• Excellent verbal and written communication skills and ability to communicate at multiple levels of an organization.
• High level of attention to detail
• Experience reading drawings, specifications and performing hands-on measurement & inspection using gauges and tools
• 2+ years experience in a regulated industry like medical devices or pharmaceutical products. Experience with FDA GMO’s and ISO 13485 experience a plus.
• 2+ year experience working in Quality Assurance / Quality Control.
• Familiarity with ERP systems
• Must be hands on and willing to work/function at many levels
• Lean Manufacturing/Lean Thinking experience is a plus
• Excellent PC skills using Outlook, Word and Excel
• Ability to organize and judge priorities

This is for a permanent full-time position to start immediately.

Salary/Benefits:

Salary competitive and commensurate with experience. The benefits include working in a great atmosphere with friendly co-workers, medical, dental & vision coverage, vacation/holiday/sick time, a 401(k) retirement plan with company match, and lots of opportunity to learn new things.

Candidates Only, No Recruiters

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.