Quality Manager

Job Summary:

Consolidated Sterilizer Systems is a leading manufacturer of steam sterilization systems, providing solutions for life sciences and health care customers for more than 70 years. We are seeking a Quality Manager to ensure that all products are designed and produced according to medical device and other regulatory guidelines while meeting customer requirements, product specifications and process parameters. This role oversees a small, close-knit team and requires a leader who is both strategic and hands-on. The ideal candidate will be comfortable rolling up their sleeves to support day-to-day operations while also guiding team members, setting priorities, and driving performance. This is a working manager role, well-suited for someone who thrives in a dynamic environment and leads by example.

Responsibilities:

• Lead the management, operation and improvement of the company’s Quality Management System.
• Work closely with various cross functional team members to ensure all products are produced to meet all customer and technical specifications and regulatory requirements applicable to the medical device and life sciences markets.
• Manage the documentation, administration and operation of the Quality Management System. Engage the cross functional team to ensure support, and adherence to the system. Work to continuously improve the process and instill a culture of quality across the company.
• Oversees Quality Control team member(s) and all Quality Control duties.  These include inspection of purchased parts/materials/products, and equipment calibration process/reporting.
• Enhance and manage the Non-Conformance Report (NCR) process/reporting.
• Manage the corrective and preventative action process (CAPA).
• Manage the complaint handling system.
• Manage all internal and external quality systems audits and ensure timely response to any audit concerns.
• Participate in new product/project development to ensure quality requirements are established.
• Participate and support lean/continuous improvement initiatives and safety initiatives.
• Lead the development and upkeep of procedures such as work instructions, QC checklists, forms, etc. as required to maintain compliance and improve quality performance.
• Work with production employees to resolve quality related manufacturing issues.
• Serve as Management Representative responsible for representing site to all regulatory bodies including registered notified bodies and ensuring management review activities are conduct per regulations.

Requirements:

• Associate’s or Bachelor’s degree in engineering, or another technical field.
• Minimum of 5 years experiences in manufacturing, with at least 5 years of combined Quality Management and Quality Control experience.
• Experience in the medical device industry (FDA) required.
• Experience in a metric-driven culture, emphasizing performance improvements.
• Previous involvement in Quality audits or leadership of audit sections desirable.
• Knowledge and Experience with ISO Quality Systems requirements, FDA,GMP, and QSR
• Proficiency in using Electronic Quality Management Systems.
• Familiarity with the ASME Codes and Standards is a plus.
• Strong data analysis and interpretation skills.
• Effective leadership, organizational, and management abilities.
• Strong reasoning and judgment capabilities, keen attention to detail.
• Excellent communication skills (both written and spoken) for effective intra-organizational communication.

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

Salary/Benefits:

Salary range is $135,000 to $150,000, commensurate with existing skills & 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.