Quality Systems Manager Job Description
Quality systems manager
provides guidance and advice on methods, procedures, standardization and requirements associated with the deviation, CAPA and EV systems.
Quality Systems Manager Duties & Responsibilities
To write an effective quality systems manager job description, begin by listing detailed duties, responsibilities and expectations. We have included quality systems manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Ensure generated metrics are reported consistently throughout the organization
Work with Business Process owners to identify trends in data related to the health of the each process, and assist Business Process owner with recommendations to correct identified negative trends
Provides Quality leadership / guidance on all QMS matters product compliance to the facility
Usually the top management representative with authority to ensure that a QMS system is established implemented and maintained within the facility
Manages the daily activities of the functional Quality organization ensuring adequate resources are in place for compliance, cross training is happening to maximize the Quality staff
Plans, directs, and develops direct reports and supports the work efforts of indirect employees including overseeing the training of Inspectors and Quality Engineer's within the their assigned area of responsibility in the application of inspection processes, customer requirements, Provide leadership in the balancing of compliance practices with other business initiatives to allow all objectives of the business to be satisfied
Provides support to functional leadership by gathering and analyzing Quality information, programs, and initiatives
Guides implementation of QIP (including rubber and EVA rooms) systems and laboratory set-ups, standard SOPs for polymer compounds at new T1 facilities
This person will lead a strategic portion of the IT department in a fast-paced environment within a highly innovative, growth-oriented company
Point of contact for all customer issues, queries or complaints internal contact point for customer services, commercial, Department of Agriculture
Quality Systems Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Systems Manager
List any licenses or certifications required by the position: ISO, QMS, 9001, TS, ISO9001, ASQ, A.S, EFFCI, BRC, USP
Education for Quality Systems Manager
Typically a job would require a certain level of education.
Employers hiring for the quality systems manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Engineering, Science, Technical, Chemistry, Education, Management, Biology, Business, Manufacturing, Microbiology
Skills for Quality Systems Manager
Desired skills for quality systems manager include:
Statistics
ISO 13485
GMP
Quality systems requirements and process ownership
8D
Medical device regulations
Regulations and standards
Applicable procedures
Basic Quality Assurance methods and tools
CAPA and EV systems management
Desired experience for quality systems manager includes:
Ability to read and interpret comprehensive and intricate research documents
3rd level qualification in scientific or technical discipline
At least 3 years' experience in Quality Assurance/Quality Systems with a background in Quality or Food Safety Management Systems with Infant Formula (preferred) Food, Biotechnology or Pharmaceutical Background
Attention to detail and ability to analyse and interpret data
Understands and is knowledgeable in methods and plant processes (including the Quality Manual, CdC’s, plant SOPs/WI)
Management of Customer Complaints, including sample reception, recording, coordinating required testing/investigation, completing reports, and communicating results
Quality Systems Manager Examples
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Quality Systems Manager Job Description
Job Description Example
Our innovative and growing company is looking for a quality systems manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality systems manager
- Assist with the Quality Management system for Document Control software
- Participates in the training and qualification of staff, creation and review of batch production and testing and generation of facility compliance documentation
- Develop internal measures to ensure compliance with the QMS
- Must be a team player with superior interpersonal, verbal and written communication skills and interface effectively throughout all levels of the company
- Analyzes data to determine performance level of suppliers
- Work with resident government and/or customer quality personnel to interpret or reach agreement on procedures and performance of equipment
- Works with process experts and production personnel to fully understand and provide guidance on appropriate and complete corrective actions to assure repeat deviations do not occur
- Conducts root cause analyses and ensures root cause, corrective action, preventative action, and product impact are thoroughly addressed in investigations
- Business process owner for Enterprise Laboratory Systems
- Develops and maintains Quality Systems for commercial stage pharmaceutical products
Qualifications for quality systems manager
- Attendance is a required function of performance for this position
- Strong leadership, collaboration and relationship building skills
- Strong interpersonal skills and multi-cultural /intercultural awareness
- Individual may be required to sit for extended periods
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy
- Completes routine tasks with no supervision
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Quality Systems Manager Job Description
Job Description Example
Our company is growing rapidly and is hiring for a quality systems manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality systems manager
- Identify, minimize and or escalate product level risk and liability throughout design, manufacturing and use in the field
- Recruit, train, and manage and lead QA personnel
- Manage and execute to the financial goals defined, break-even P&L with a blended project rate of 40/60 division of hi-cost and lo-cost sites
- Maintain strong “Continuous Improvement” initiatives
- Create and promote an active Quality Mindset, “Create the Culture”
- Maintain and support ISO Certification
- Effectively challenge the Project Management and the technical teams on continuous improvement and problem resolution
- Conduct audits in a constructive and team oriented fashion
- Respect other cultural and organizational differences
- Conducting certification and surveillance audits with Third Party Agencies
Qualifications for quality systems manager
- Minimum 5 years in a management position with commercial stage pharmaceuticals
- Positive work attitude that supports teamwork and continuous improvement
- Knowledge of federal, state, local, and accreditation agency regulations
- BA/BS degree in scientific or engineering discipline
- Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals
- Fluency (both written and oral) in English is required
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Quality Systems Manager Job Description
Job Description Example
Our growing company is looking for a quality systems manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality systems manager
- Oversees and manages Quality Systems
- Facilitates and manages the internal and external proficiency testing program
- Liaising with relevant Regulatory Bodies Notified Body and Competent Authority
- In partnership with the site Quality leaders, oversees the Product Escalation process for non-conformances, complaints or other issues potentially impacting product in the field
- Document Control analysts
- CAPA and Complaint Coordinators
- Technically proficient in the specific quality systems department and knowledgeable of industry practice and business principles
- Makes recommendations for corrective action necessary to ensure conformity with quality specifications
- Update, maintain and publish Audit Calendar
- Ownership of the vendor qualification process, change control system, complaint program, training program, mock recall coordination, SOPs / metrics and coordination of Quality Steering Committee
Qualifications for quality systems manager
- Minimum of 10 years of professional experiences
- Whereas minimum of 5 years as Quality, UAP, Plant Manager or FES Senior specialist
- Target and Process orientation
- Ability to manage a complex network in a matrix organization
- Ability to travel aboard for more than 75% annually
- Minimum bi-lingual (English and spanish required)
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Quality Systems Manager Job Description
Job Description Example
Our company is hiring for a quality systems manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality systems manager
- Be involved in staff recruitment and appraisals and training of staff to deliver a high standard of QMS business processes as required
- Maintain and further develop the appropriate performance measurements for the department and report at the quarterly management review meetings
- Conduct and /or attend operational staff management meetings
- Conduct regular departmental meetings to ensure everyone is informed of process/ procedures/ departmental performance and training plans
- Act as the main point of contact for QA leadership for the organization at the campus
- Work with all functional departments to ensure appropriate communication of status, positive and adverse trends and continuous improvement opportunities
- Be an active and positive member of the management team, contributing to the overall professional management, development and operation of the company
- Contribute on matters of Health & Safety and staff welfare
- Provide back up to other departments/ groups as required
- Attend training courses in the UK and USA as required
Qualifications for quality systems manager
- Expertise in 6-sigma and ASQ principles and standards
- Be knowledgeable on Quality Standards
- Quality Shareplace management
- Regional and overseas travel will be required
- Biotechnologies degree (or equivalent scientific degree) with Italian Public Register inclusion to sign Laboratory documentation
- At least 10 years of experience in the same role within biomedical context
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Quality Systems Manager Job Description
Job Description Example
Our innovative and growing company is looking for a quality systems manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for quality systems manager
- Leads coordination and execution of internal self-inspection audit program
- Selects and retains staff
- Manages and develops IT Quality System direct reports
- Internal Audits – Planning, Scheduling and completion
- Monitor the closure of any action items found during the internal audits
- Monitor the QSi document control database - notification process
- Coordinate the Plant’s External Audit Process
- Response to any BV – IAFT audit findings
- Monitor the closure of any action items found during the BV external audits
- Lead the Quarterly Management Review with the Plant Manager
Qualifications for quality systems manager
- Good knowledge of international regulations - supported by specific trainings - and Quality Systems management belonging to medical field
- Knowledge of regulatory requirements (ISO, QSR, ), preferred
- PE, ISO 9001 Certification
- 8+ years with at least 5 years applicable Quality Management
- Able to develop plans and policies
- Able to implement plans and policies across broad spectrum of the program