Quality Assurance Quality Control Manager

Acute Care Technology This position is responsible for developing, implementing and managing quality assurance and quality control program designed to ensure continuous production of electrodes consistent with established standards, customer specifications and production goals.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won't just have a job. You'll have a career-and a purpose.

Join our team. It's a great time to be a part of ZOLL!

Job Type

On Site

Job Summary

This position is responsible for developing, implementing and managing quality assurance and quality control program designed to ensure continuous production of electrodes consistent with established standards, customer specifications and production goals.

Essential Functions

* Manage and provide guidance to personnel engaged in final and incoming inspection and testing activities, quality assurance specialists and quality technicians.

* Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection.

* Create, document and implement inspection criteria and procedures.

* Provide and oversee inspection activity for product throughout production cycle.

* Collect, analyze and disseminate quality data throughout the organization.

* Design, develop and implement quality control training programs.

* Work with supervisors to ensure sufficient inspection coverage.

* Participate in Material Review Board activities.

* Act as quality signatory on processing non-conformances and provide guidance on disposition and containment of non-conforming material.

* Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements.

* Must be able to work in and promote a Team environment and work collaboratively with all departments as necessary to ensure quality issues are rectified.

* Provide support and participate in internal and external audits. Ensure inspection readiness of the facility.

* Develop and implement quality improvement programs.

* Compile and coordinate the completion of monthly quality metrics and ensure the review of the departmental metrics.

* Lead departmental effort in CAPA investigation and completion.

* Support the maintenance of the Calibration program.

* Participate in validation and verification planning activities, including protocol and report review as needed.

* Participate in Change Order review and approval activities as needed.

* Maintain and monitor team workload, performance, and quality.

* Assess and manage direct reports' learning and development opportunities.

* Conduct annual and ongoing performance reviews with recommendations for compensation changes, promotions, and disciplinary action as appropriate.

* Participate in the interviewing, hiring, and retention of highly engaged and diverse employees.

* Set a professional example in alignment with ZOLL's Leadership Qualities.

* Execute company strategic business plans and long and short-term objectives.

* Provide leadership, direction, and mentorship to other members of the leadership team.

* Seek out opportunities to mentor and lead cross-functional and cross-divisional teams.

Required/Preferred

Education and Experience

* Four-year degree in technical or science discipline required

* 4-6 years related experience in a regulated environment, preferably medical device is required

* 1-3 years experience in supervisory/management role is required

Knowledge,

Skills and Abilities

* Proficient at problem solving - analytical and diagnostic proficiencies

* Strong communications skills to include presentation capabilities

* Excellent verbal & written communication skills.

* Experience with ISO 13485 and FDA QMSR for Medical Devices and FDA Quality System Requirements preferred

* Must be able to promote a Team environment and work collaboratively with all departments as necessary to ensure quality issues are rectified.

Preferred Languages

* English - Advanced

Travel Requirements

* 5% Travel both locally and domestically to facilities for meetings, collaboration, coordination, and/or training.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

* Standing - Occasionally

*…