Supervisor, Quality Engineering

The Supervisor, Quality Engineering in our Temecula, California facility 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 Quality Manager for the facility has responsibilities beyond the immediate management of the facility.

The Supervisor Quality Engineering is the on-site subject matter expert for the quality system and its performance. Under direction of the Quality Manager, the Supervisor, Quality Engineering 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.

In this role you will provide guidance and direction to Quality Technician(s) and Quality Analyst(s). The Quality Supervisor 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 Quality Supervisor 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.

This position requires onsite work Monday through Friday 7:30am to 4:00 pm with additional availability during the week or occasional weekend hours based on business needs.

While the role is primarily based at Temecula, California, occasional travel (approximately 20%) may be required to support other facilities within our network, including our Ontario, California site based on business needs.

• Lead day-to-day tasks, assignments and direction for all Quality Associates, provide technical support, mentorship and oversight of assigned duties and objectives.
• Responsible for all the accuracy and conformance of all product 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.
• Review/approve protocols and final reports, escalate deviations from performance standards, monitor and manage quality employees in their execution of the site's CAPA, non-conformance and Customer complaint processes.
• Draft and review quality system work instructions and maintain quality metrics reporting and countermeasures.
• Responsible for self-monitoring of the site quality management system, as well as conducting internal audits at sister facilities to ensure the quality system meets regulations and standards. Perform related tasks such as pre-planning, execution and report writing.
• Support, in conjunction with the Senior Regulatory Manager, Agency and Notified Body inspections.
• Lead Customer audits and are 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.
• Establish objectives, mentor direct reports, manage resources, conduct performance check-in's/reviews, development plans and support employee development.
• Demonstrate leadership by driving continuous improvement at their site while maintaining the integrity and compliance of the quality management system.
• Lead continuous improvement initiatives for the facility, actively engage and participate in assigned projects (facility-level, regional-level and global-level) and 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.
• Ensure external and internal requirements are met according to documented policies, procedures, standards and regulations.
• Foster a positive work environment through regular engagement with Quality team members and members from other functional areas.
• Perform all other duties as assigned.

Required:

• Bachelor's degree in scientific or related technical field.
• Minimum of 9 years of experience in manufacturing or processing environment or related scientific or technical environment.
• Minimum of 8 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum of 8 years of experience working in an ISO certified environment required.
• Minimum of 3 years supervisory/project leadership/oversight required.
• Excellent problem-solving skills.
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Effective interpersonal skills, ability to work independently under minimal guidelines and supervision.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to multi-task and work in a fast-paced, regulated environment with strict deadlines and ever-changing responsibilities.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.
• Ability to travel up to 20% to other facilities including Ontario, California.

Preferred:

• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Sterilization experience preferred.
• Minimum of 8 years of experience with medical device or other regulated industries preferred.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Unique exposure to multiple sterilization modalities across our network, offering rare and valuable learning opportunities in this niche industry-supporting your long-term professional growth and development
• Excellent opportunities for learning, growth and advancement in a stable long-term career

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