Quality Engineering Lead

Position Summary

The Lead, Quality Operations is directly responsible for execution of the quality management system by managing processes, leading projects and directing associates to maintain and improve the quality system in accordance with the requirements of, as appropriate, the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. 

This role may reside in a facility where the Senior Quality Manager for the facility has responsibilities beyond the immediate management of the facility. The Lead is the on-site subject matter expert for the quality system and its performance. Under direction from the Senior Quality Manager, the lead is responsible for all matters pertinent to maintaining sustainable, repeatable, and compliant quality processes. This role recommends, plans, and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems. 

Through guidance and direction to Quality Technician(s) and Quality Analyst(s), the Lead is responsible for all activities related to quality and regulatory compliance to ensure all product processing requirements are met in accordance with Customer specifications. This includes responsibilities for all sub-parts of the quality system including calibrations, dosimetry results, generation of test methods, audits, scheduling, validations, record keeping and reporting. 

The Lead has the responsibility, duty, and decision-making authority to put any product on hold that is identified as potentially non-conforming and escalating as needed for additional reviews by Quality leadership and/or Technical teams.

 Pay range for this opportunity is $91,250-$120,000. This position is eligible for bonus participation. 

What you will do:

• Leads day-to-day tasks, assignments, and direction for all Quality Associates, providing technical support, mentoring and oversight of assigned duties and objectives. 
• Ultimately responsible for all the accuracy and conformance of all products released from the facility, by maintaining independence and oversight of all product review and approval activities.
• Direct all activities associated with the site’s quality system through data analysis, reviewing/approving protocols, and final reports, escalating deviations from performance standards, monitoring and manage quality employees in their execution of the site’s CAPA, non-conformance and Customer complaint processes, drafting and reviewing quality system work instructions and maintenance of quality metrics reporting and countermeasures. 
• Responsible for self-monitoring of their site’s quality management system, as well as, conducting internal audits at sister facilities to ensure the quality system is meeting regulations and standards. Includes performing related tasks such as pre-planning, execution and report writing. 
• Responsible for supporting in conjunction with the Senior Manager, Regulatory Agency, and Notified Body inspections. Responsible for leading Customer audits. Accountable to the results of these inspections, including inspection observation investigations and collaboration with other department managers to develop and implement sustainable and effective remediation plans.
• Responsible for establishing objectives, mentoring direct reports, managing resources, conducting performance check-in’s/reviews, development plans and supporting employee development. 
• Demonstrate leadership by driving continuous improvement at their site while maintaining the integrity and compliance of the quality management system. Executed by leading continuous improvement initiatives for the facility, actively engaging and participating in assigned projects (facility-level, regional-level and global-level) and effectively implement global process and other harmonization of processes at the site. 
• Travel to other AST facilities, domestically and/or globally, to support remediation activities, audits/inspections and/or continuous improvement initiatives. 
• Overall responsibilities include commitment to ensure external and internal requirements are met according to documented policies, procedures, standards, and regulations. 
• Perform all other duties as assigned.
   

What you will need to succeed:

• Bachelor’s Degree (Scientific or related technical field)
• 8+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience
• 8+ years of experience with medical device or other regulated industries preferred
• 8+ years of experience working in an ISO certified environment required
• Supervisory/project leadership/oversight preferred
• Sterilization experience preferred 
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred
   

What we offer

The opportunity to join a company that will invest in you for the long-term. STERIS couldn’t be where it is today without our incredible people. That’s why we share in our success together by rewarding you for your hard work. Hiring people who are in it for the long run with STERIS is our ultimate goal. We do this by providing: 

• Competitive pay
• Annual merit bonus and incentive plans
• Medical, vision, prescription, dental and life insurance
• 401(k) with a company match
• Paid vacation time and paid holidays
• Tuition assistance
• Opportunities for advancement

Join us and help write our next chapter.

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