Quality Systems Job Description

Quality Systems Job Description

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Quality systems provides leadership, technical, and subject matter expertise to ensure conformance to ISO, FDA, & MDD/DMR based quality systems elements relating to product commercialization.

Quality Systems Duties & Responsibilities

To write an effective quality systems job description, begin by listing detailed duties, responsibilities and expectations. We have included quality systems job description templates that you can modify and use.

Sample responsibilities for this position include:

Develop, implement, communicate and maintain a quality plan to bring the facility’s Quality Systems and Policies into compliance with ISO/cGMP Quality system requirements
Handle the administration, effectiveness and continuous improvement for these systems which receive information from multiple quality systems
Initiate and author internal McNeil Quality Systems investigations and CAPA records when necessary and will support the preparation, review, processing, approval, and closure of change controls, as applicable
Facilitate training sessions and meetings as applicable and assist in the periodic review of quality systems
Manage the scheduling and coordination of international audit teams and customer quality system audits worldwide
Coordinate the monthly Worldwide management Review meetings including scheduling presenters, preparing documentation, and follow up of Action Items assigned during meetings
Manage and coordinate the issuance of training matrix records, follow up to completion all training matrix records, document all training into the division’s training system database for the Wisconsin locations
Identify and provide training for all internal auditors
Conduct and report on periodic internal gap analysis on all operations compared to world class criteria
Serve as subject matter expert on our ISO 9001 procedure and all quality management systems

Quality Systems Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Systems

List any licenses or certifications required by the position: ISO, ASQ, TS, 9001, SSBB, QCMS/QRMP, GMP, TSE/BSE, CCC, IATF

Education for Quality Systems

Typically a job would require a certain level of education.

Employers hiring for the quality systems 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, Education, Technical, Chemistry, Biology, Business, Manufacturing, Management, Microbiology

Skills for Quality Systems

Desired skills for quality systems include:

ISO 13485
GMP
FDA
MDD
Excel
Quality Systems
Quality systems and regulatory requirements
Standards

Desired experience for quality systems includes:

Periodic Travel maybe required 5-10% Mostly Domestic
Recommend remediation plans required to secure continued on time, in full compliant product
Follow-up of the company's quality investigation queries by onsite review with facility, procedures, practices and records
Facilitate and coordinate change control processing which impact routine batch release
Provide regulatory inspection support for inspections which impact the company's products and follow up any resulting quality improvement or remediation action plans
A primary degree in a Science/Engineering discipline

Quality Systems Examples

1

Quality Systems Job Description

Job Description Example
Our growing company is looking to fill the role of quality systems. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality systems
  • Ensure the implementation of applicable compliance standards
  • Supervises Quality Systems Engineers
  • Backup AA when required
  • System administrator duties for QC systems, including TipQA
  • Support and maintenance of the applications
  • Maintenance of system reports, including generation and management of the Certificate of Analysis report
  • Template configuration and validation
  • System documentation, including SOPs, protocols, training manuals
  • Troubleshooting and resolving issues to avoid production delays
  • Creation, review and completion of local and global Change Controls
Qualifications for quality systems
  • Professional certification in the quality profession
  • Minimum 5 years Quality experience in medical device industry, including
  • Excellent verbal and written communication skills with various levels of the organization
  • Demonstrated proficiency with Microsoft Software and other Computer applications (SupplyWeb, QSI, Lotus Notes etc)
  • Ability to work with a high degree of accuracy and strong attention to detail (documentation reviews, audits and recommendations made by senior management, customer and external auditors)
  • Possess or develop familiarity with Occupational Health and Safety Act & Regulations
2

Quality Systems Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality systems. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality systems
  • Audit Operations support departments for compliance to SOP’s and GMP’s in internal quarterly and annual audits
  • Identify & Implement improvements for greater efficiencies from QC systems
  • Creation, review and management of material certifications
  • Implement updates to system by working with Corporate TipQA team and communicate issues/upgrades needed to Corporate team for local site applications
  • Work closely with the TipQA system administrators at other sites, particularly Asheville and CMC Process and Analytics team to discuss and resolve issues, and to ensure harmonized processes exist
  • Evaluate alternative technologies for QC activities to achieve greater efficiencies
  • Attend or ensure the attendance of appropriate site SMEs to ad hoc meetings to discuss quality intelligence
  • Assists with the integration of Quality Risk Management principles and practices into the Quality System, along with applicable area management
  • Perform all type of testing (functional, compliancy, security, load )
  • Perform tests in different level according to project life cycle (integration, progression, regression, acceptance tests)
Qualifications for quality systems
  • Minimum of bachelor's degree in Information Technology/Science or equivalent related discipline
  • Experience of lab processes and lab organization
  • Experience of LIMS and/or SAP QM is a strong advantage (training will be provided)
  • Record of high achievement and delivery
  • Proven Self Starter with drive and determination
  • Excellent leadership, presentation and communications skills
3

Quality Systems Job Description

Job Description Example
Our innovative and growing company is looking for a quality systems. 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
  • Working with site and corporate management, ensures the effective implementation and maintenance for Quality System requirements, including but not limited to, MDD 93/42/EEC, ISO13485, CMDR, and 21CFR 820
  • Ensures quality systems are effectively deployed
  • Responsible for leading the efforts and compliance with Lean Six Sigma practices for the department
  • Initiates and maintains contact with and determines the requirements of outside 3rd party accredited agencies such as NSF and USP
  • Generates and communicates weekly and monthly reports and trends for Deviations/CAPA, Change Controls, Consumer Complaints, and outstanding audit findings
  • Reviews daily complaints and initiates contact with Customer Relations and CMOs to prompt return of complaint products
  • Composes appropriate response to Consumer Relations as follow up to consumer complaint investigations
  • Support Change Control and Non Conformance reports to drive closure in a timely manner
  • Create, develop and manage Standard Operating Procedures (SOP) for Operations departments
  • Actively participate in closing CAPA reports by working with applicable departments and verifying that corrective action was completed/ implemented as required
Qualifications for quality systems
  • Ability to display a high degree of professionalism in dealing with managers and users
  • BS Degree in a Science or Engineering field, Masters preferred
  • Minimum 5 years of experience in a quality management role
  • Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Quality)
  • Minimum of 3 additional years of experience in Business Process Management
  • Strong computer skills using MS Office products ERP system experience is desired, Syteline experience preferred
4

Quality Systems Job Description

Job Description Example
Our innovative and growing company is hiring for a quality systems. 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
  • Proactively communicate with all internal customers on key quality issues
  • Perform learning management system (LMS) transactions including user, item, and curriculum management, reports generation, and maintenance of content and completions
  • Work with the ISO / TS 194949 Core Tools
  • Ensure customer specific requirements are met
  • Responsible for project work as needed
  • Lead the CAPA process ensuring corrective actions (CAPA) are completed in accordance with ISO requirements (incl
  • Perform internal audits, when required as lead or associate auditor
  • Oversees and manages the day to day operations of the CGMBS training program including the class recordings, lecture/practical scheduling, exams
  • Facilitates the training and competency assessment program for all applicable staff
  • Assist in maintaining and controlling the Quality management systems for manufacturing, laboratory and support functions
Qualifications for quality systems
  • Extensive knowledge of quality assurance theories, principles, practices, techniques, and concepts
  • Diploma / ITC / NTC
  • Minimum 3 – 5 years relevant experience in handling training or quality documentation and administration for large multi-national manufacturing organization
  • Desktop applications, analytical tools, presentations, document management
  • Experience working in medical device, pharmaceutical or related industry will be preferred
  • Able to solve technical problems, autonomous and decision making abilities, requires minimal supervision
5

Quality Systems Job Description

Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality systems. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality systems
  • Assist in supporting the compliance team in routine activities as required
  • Oversee PRI Nadcap audits
  • Oversee FAA oversight audits at 13 distributor hose shops
  • Decatur, AL
  • The position recognizes that accident and injury prevention are equal in importance to production, quality, delivery, recovery and cost control
  • Manage compliance with relevant GMPs and promote quality improvements
  • Ensure adherence to internal and external regulatory requirements
  • Site CAPA Leader - ensure investigations are conducted and adequately resolved in a timely manner with appropriate actions in place to prevent reoccurrence of issues
  • Reviews, directs and manages manufacturing and pharma QA strategies, organization, and execution for results
  • Collaborate with Rice Creek, Monmouth Junction, and MMI operations teams other internal and external partners to ensure the strategy is executed to achieve significant and measurable results
Qualifications for quality systems
  • Good communication skills with people from all levels in the organization
  • Knowledge and experienced with Quality methodologies
  • BS in a scientific discipline preferred
  • Ability to effectively lead, manage and participate in cross-functional problem solving teams
  • Ability to work independently, within groups
  • Experience leading APQP (advanced product quality planning) and performing FMEA (failure mode and effects analysis), PPAP (production part approval process), and SPC (statistical process control) submitting documentation according to AIAG (automotive industry action group) guidelines

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