Quality Assurance Engineer

Acute Care TechnologyResponsible for supporting the Quality Assurance organization with quality improvement, supporting manufacturing, troubleshooting quality issues and monitoring quality trends; and interfacing with R&D to support new product introductions. Primary responsibilities are to prepare and maintain necessary documentation, monitor production quality performance to identify opportunities for improvements, act as a liaison between manufacturing and quality to promote quality awareness.
Essential Functions:
Collaborate across functions, demonstrating quality and manufacturing expertise to solve problems, interpret data, and determine next steps.
Lead product complaint investigations, driving completion from receipt to resolution
Complete health risk assessments from product complaints or internal product/process/system issues
Develop and implement quality improvement programs
Support planning, review and approval of manufacturing process validations
Participate in change control activities for documents, manufacturing and QA/QC
Provide technical guidance to QA and QC personnel
Represent quality interests and concerns on project teams
Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements
Collect, analyze and disseminate quality data throughout the organization
Participate in Material Review Board activities, including resolution of product nonconformities
Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements
Participate in Risk Management activities
Monitor production quality performance to identify opportunities for improvements
Engage and interface in internal and external audits providing subject matter expertise.
Participate in the CAPA program as a trained CAPA lead
Other duties as assigned
Required Skills
Competencies:
3+ years related experience in a regulated environment, preferably medical device
Proficient at problem solving
Excellent verbal & written communication skills.
Familiar with Statistical Analysis
Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines
ASQ Certified Quality Engineer desirable
Education:
Four year degree in a science or engineering related disciplineAt 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 wont just have a job. You'll have a careerand a purpose.

Join our team. Its a great time to be a part of ZOLL!

Job Summary

Performs a variety of complex tasks related to Quality Assurance including, but not limited to: performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software.

Essential Functions

• Performs internal quality audits and effectiveness reviews (FDAs QSR, ISO 13485, MDD, CMDR). Conducts supplier evaluations and audits.
• Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
• Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
• Responsible to build and improve key business relationships within the organizations cross functional departments.
• Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
• Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
• Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
• Prepare, submit and coordinate the process validation requirements for non-product software validations.
• Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
• Participates in the nonconforming material/Material Review Board process. Championing the implementation of Lean Manufacturing processes.
• Participate in Kaizen events as a representative of the quality department.

Required/Preferred Education and Experience

• Requires a BS degree required or
• Equivalent experience in a technical or scientific discipline required
• Experience in an FDA regulated Class III electrical medical device manufacturing environment required and
• Experienced in process development and validation for electro-mechanical assembly, test, and service. required and
• Formal Project management experience a plus preferred and
• Lean experience preferred and
• Experience with database queries and reporting in SQL or Microsoft Access preferred
• Six Sigma Green Belt Certification Preferred and
• Black Belt Preferred

Knowledge, Skills and Abilities

• Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Working Conditions

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.