Quality System Compliance Manager Job at ZEISS Group
$84,000 - $100,000 a year
SUMMARY:
To support maintaining Quality System Compliance practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QSC Manager is responsible for providing leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. The QSC Manager will proactively monitor the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. The QSC Manager will be responsible for working with R& D, Engineering, Manufacturing and Quality Control to coordinate the activities required for nonconformance investigations including failure analysis and deviations.
To support maintaining Quality System Compliance practices in adherence to the Food and Drug Administration (FDA) regulations for the Quality System Regulation and for ISO 13485 standards, the QSC Manager is responsible for providing leadership in the implementation, maintenance, and improvement of company-wide quality management systems, procedures and support processes. The QSC Manager will proactively monitor the various elements of the quality system to help ensure compliance with quality system regulations and applicable national and international quality standards. The QSC Manager will be responsible for working with R& D, Engineering, Manufacturing and Quality Control to coordinate the activities required for nonconformance investigations including failure analysis and deviations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provides support to internal functions in the application, maintenance and improvement of quality systems and department specific processes.- Provides hands on support to international CZM sites to facilitate the development of quality systems and business processes.
- Responsible for ensuring that the site quality systems are in compliance with the applicable regulations and national & international quality standards.
- Provides support to internal functions in the application, maintenance and improvement of quality systems, procedures and department specific processes;
- Manages activities related to Health Hazard Evaluations (HHE) and field actions to ensure compliance with applicable regulatory requirements.
- Supports external audits by the FDA, the Notified Body, other regulatory bodies and third parties, and coordinates responses to applicable audit findings.
- Supports external customers to provide documentation in support of requests to provide evidence of implementation of a certified quality system
- Responsible for maintaining the NCR, and Deviation Quality Assurance programs and being involved in the investigation and problem resolution efforts for nonconformities.
- Responsible for the timely issuance of quality related documentation (NCR’s, Deviations, etc.) and the generation of monthly KPI reports as well as the tracking of the noted issues through to timely completion, updating of tables and the reporting of QMS trends.
- Work as a key resource for cross functional departments to assist in compliant processing while maintaining efforts to plan, establish, maintain and improve production levels.
- Maintain quality control principals as they relate to investigations, product quality and surveillance practices.
- Maintain and improve quality awareness to keep rejects to an acceptable level.
- Participate in the development and implement programs aimed at building employee competence as well as encouraging active participation in product and process improvements.
- Responsible for hiring, training, periodic reviews and release of employees.
- Supervise QA Complaints Specialist in the reporting of product returns from complaints, as well as the results of investigations in a timely manner.
- Supervise four (4) to eight (8) Quality Control team members over multiple functions and shifts.
- Recommend improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
- Complete projects in a timely manner and consistent with corporate objectives.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
H.S. Diploma with 5+ years relevant related experience- Bachelor’s degree in engineering, clinical sciences, related sciences is preferred.
- 1+ year of post-market complaints experience in a medically regulated industry with an understanding of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and FDA QSR.
- Medical Device and or other regulated industry (Pharma, IVD,) preferred.
- Must be able to work as a team to gather information needed to understand and solve problems
- Experience in Technical Writing
- Experience with creation and writing procedures or policies
- Advanced computer skills preferred
- Quality Management software knowledge preferred
The annual salary range for this position: $84,000-100,000
The salary offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.
This position is also eligible for a performance bonus or sales commissions.
ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.
Your ZEISS Recruiting Team:
Christina Choing
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