Job SummaryThis individual will drive Quality Improvements through the Corrective and Preventative Action program in a cross functional environment. Support the Organizations Internal Audit program and participate in external audits to ensure we maintain regulatory compliance. Assist with content review for Quality System documents and regulatory communication.
Due to the on-site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Chelmsford, MA). This role does not offer relocation. ZOLL Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future.Essential Functions- Review CAPA(s) for appropriate content Monitor and Manage CAPA KPl(s) to objectives
- Ability to lead a cross-functional team through CAPA
- Maintain and look for opportunities to continuously improve the CAPA process and compliance to all applicable regulations
- Conduct appraisals program yearly or as needed for CAPA Leads Assist in the development, training and expectation for CAPA Leads Assist in the management and scheduling for Internal Auditing Ensure internal audit finding response time meets internal targets Ensure timely closure of internal audit responses
- Participate in external audits related to manufacturing site under QMS umbrella Ensure timely QS compliance related to SOP review
- Assist in the review of Health Risk Assessment's
- Assist in the development and review of Competent Authority, Registrar and Regulatory Agency correspondence
- Support managers and supervisors to define training requirements and ensure employees are trained to adequately perform their assigned responsibilities related to the Quality Management System.
Required/Preferred Education and Experience- Four-year degree required
- Minimum 5 years related experience in a regulated environment, preferably Medical Device Industry preferred
Knowledge, Skills and Abilities- Excellent written, verbal and interpersonal communication skills Proficient time management and project management skills
- Experience with FDA QSR, ISO13485, MDD and MDR, MDSAP and ISO14971 for Medical Devices
- Proficient with auditing techniques
The annual salary for this position is:
$90,000.00 to $110,000.00
Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.
