Quality Process Manager Job Description
Quality process manager
provides guidance and ensure business practices are in alignment of the Quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements.
Quality Process Manager Duties & Responsibilities
To write an effective quality process manager job description, begin by listing detailed duties, responsibilities and expectations. We have included quality process manager job description templates that you can modify and use.
Sample responsibilities for this position include:
Develops quality assurance plans by conducting hazard analyses
Determining the quality assurance requirements which will insure compliance of in-process and final production are in compliance with company and customer quality standards and delivery requirements
Ensuring adherence to ISO9001, AS9100, and FAA regulations other Aerospace Industry requirements and Government regulations
Determine manufacturing impact of quality specifications, drawings, and purchase orders
Evaluates customer contractual specifications, and determines and implements Quality Assurance requirements specified by customer contract
Acts as a liaison and as a technical resource internally to support areas such as Program Management, Design Engineering, Manufacturing Engineering, Manufacturing Supervision and Quality Engineering in analysis and resolution of production issues
Provides quality and inspections sign-off and approval for all production and repairs shipments
Responsible for assuring that the Quality Manual, Quality Procedures, Work Instructions and all other Quality forms and documentation are maintained current and are being accurately implemented by applicable departments
Monitor and facilitate adherence to ISO 9000, AS9100, FAA and other Aerospace Industry, regulator and customer driven quality systems
Directs the external audit of the Quality Management System for compliance to established customer requirements
Quality Process Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Quality Process Manager
List any licenses or certifications required by the position: ISO, RN, CPC, PMP, 9001, QMS, QA, ITIL, ASQ, HACCP
Education for Quality Process Manager
Typically a job would require a certain level of education.
Employers hiring for the quality process 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, Business, Science, Management, Nursing, Technical, Education, Chemistry, Finance, Healthcare
Skills for Quality Process Manager
Desired skills for quality process manager include:
Application of Product/Process and Quality System standards of the International Certification
Capability studies
Control Planning and PFMEA
Customer Quality Requirements
Gage R&R’s
Quality Core Tools
21 CFR part 820 and ISO 13485
Ability to apply ITIL processes and standards
Approaches and tools
Automotive quality thinking is considered
Desired experience for quality process manager includes:
Proven influencing skills to achieve results and maintain positive 360 degree working relationships, particularly one must effectively influence peers or those with more senior roles
Strong organization, time management, and communication skills essential
Experience as a key contributor cross functional teams, serving as a key representative for a given function / area
Exposure to technical aspects of the role including technical writing, systems testing, quality and compliance
Prior direct supervision of teams
Experience with testing frameworks including sampling methodologies, data analysis, and reporting
Quality Process Manager Examples
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Quality Process Manager Job Description
Job Description Example
Our company is growing rapidly and is looking for a quality process manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality process manager
- Participates as a company representative in preliminary contractual review on matters concerning quality requirements and supplier evaluations
- Improves the effectiveness of the quality engineering activity through focus on preventive corrective actions that will reduce manufacturing cost and provide increase to first time internal quality
- Plans and coordinates customer quality surveys in-house and at vendors
- Determines required tooling and instrumentation
- Performs quality audits of new and existing suppliers to assure they meet required quality standards
- Schedules customer source inspections as required per purchase order
- Provides quality planning and technical expertise on various product lines concerning quality and inspection methods
- Generates quality cost estimates to support quotations to customers
- As otherwise required, serves as liaison and provided technical support to other departments in evaluating designs for production
- Drive product and process improvements that ensure the Module Center’s quality metric goals are met (Escapes, Scrap, Rework and Process Cert)
Qualifications for quality process manager
- Develop and lead the implementation of pro-active quality initiatives which achieve strategic process, reliability and productivity improvements
- Providing direction to Quality salary and hourly personnel involved with reduction of cost of poor quality (COPQ), Module Center corrective actions, and processing of quality notifications
- Coordinates HEDIS activities as required by Physicians Health Choice coordinates HEDIS reviews with Director of Clinical Data Operations
- Works with IS to provide nurse productivity reports and analysis to senior leaders
- Ensures adequate staffing is in place to meet market demands
- Identify process improvement opportunities and champion their implementation, as assigned
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Quality Process Manager Job Description
Job Description Example
Our company is searching for experienced candidates for the position of quality process manager. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality process manager
- Provide mentoring, leadership, direction and training to new and existing (Senior) Quality Specialists
- Participate in SOP and process development as assigned
- Perform Process Lead role for Partnerships and/or key accounts or provide process support to Partnerships and/or key accounts, as assigned
- Perform Functional Quality Lead role (FQL) and conduct Functional Quality Evaluations (QE) if assigned and communicate with Project Quality Lead (PQL) and Operations
- Develop designated operational group(s) specific interventions/targeted/independent quality assessments as assigned
- Provide audit and inspection support as assigned
- Perform QC checks of Medicinal Products and other quality critical Clinical Trial Materials during receipt, production and distribution
- Oversee all Quality Control activities in local depot/warehouse
- Instruct and train QC staff and other depot staff as needed
- Perform QC release of Medicinal Product batches and batches of other quality critical Clinical Trial Materials (CTM)
Qualifications for quality process manager
- Oversee local depot and production (D&P) related change control procedures and quality issue (QI) reporting
- Closely co-operate with local Head of Production, (Sr.) Depot Coordinator and local QP (Qualified Person) or local RP (Responsible Pharmacist) to ensure smooth depot/warehouse operations
- Closely co-operate with (Sr.) GMP Lead to ensure worldwide harmonization
- GMP and GDP experience, relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Clinical Logistics Services
- Experience with primary and secondary packaging including labelling activities
- Leadership/project management/technology/business operations experience
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Quality Process Manager Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of quality process manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality process manager
- Preferably relevant experience in Quality Management preferred
- Provide training to Suppliers & Vendors and implement colour standardization where possible
- Develop & Roll out colour management standardization program with suppliers & vendors
- Analyse colour approval statistics and make appropriate changes to improve supplier, vendor performance
- Collaborate with Design to finalise seasonal palette of colours and Influence to reconcile where necessary to maintain colour integrity
- Ensure substrate is appropriate for industrialisation or provide alternate solutions
- Review requests for palette deviations throughout season and determine if new colour is needed or variation is within tolerance
- Drive evaluation and selection of a single colour management service for long term partnership
- Run tests of matching shade/substrate variations to a single standard while maintaining substrate specific variations through production
- Implement digital evaluation of colour under appropriate circumstances
Qualifications for quality process manager
- Training experience, as appropriate, required
- Relevant experience in Quality Management preferred
- Relevant experience in the Clinical Research field (pharmaceutical industry or CRO), clinical or medical experience or other relevant experience in the areas Logistics Quality Oversight (LQO) support required
- Regulatory Inspection experience
- Experience with certification and release of IMP preferred
- Experience with Import & Export of pharmaceutical products preferred
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Quality Process Manager Job Description
Job Description Example
Our growing company is looking to fill the role of quality process 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 process manager
- Supervise addition of new colours to the PLM colour library system (FlexPLM)
- Responsibility for implementation and maintenance of preventive Quality assurance tools and methods, P-FMEA, MSA, SPC and layered audits
- Provide day-to-day management and technical leadership for organizational and project aspects related to Quality System compliance
- Monitor development from requirements through acceptance testing to include walkthroughs, inspections, metrics and identified problems and trends
- Develop and maintain the Quality System
- Generate and maintain a schedule of Quality activities
- Conduct process and product assessments, and maintain assessment results in a software tool
- Monitor the supplier’s to ensure compliance to their plan and procedures
- Review results/status from the Supplier’s audits, corrective actions, and metrics
- Support milestone reviews, peer reviews, and project reviews, as appropriate
Qualifications for quality process manager
- To analyze volume information and identify opportunities to optimize, through consolidation, changes in routing, transport mode
- Proven track record of applying problem-solving frameworks, such as 6 sigma, DMAIC, PDCA Cycle
- Proven analytical and quantitative skills (includes ability to use tools such as Excel and Access)
- Represent AQR in Abbott Engineering Standards steering committee, environmental committee and process committees
- Excellent written and verbal communications and presentation in English, Chinese or other languages
- University degree in engineering with 10+ years experience or equivalent
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Quality Process Manager Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of quality process manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for quality process manager
- Track discrepancy reports, change requests and action items to include maintenance of the BendixKing nonconformance database
- Responsible for ensuring assigned projects comply with FAA standards, and requirements
- Perform process analysis for continuous improvement
- Interface with the PAAC assigned Certification Engineers to BendixKing to assure Design and Production approval activities are coordinated internally and with the FAA
- Support and where applicable perform Company and FAA conformity activities
- Support all MIDO audits of the BendixKing organization
- Participate in MIDO and ACO meetings to assure communication clarity with the FAA
- Interface with Safety, Reliability, and Verification personnel on Quality activities
- Ensure successful roll-out of the plan and sustainability as quality management becomes embedded into normal ways of working
- Establish and maintain strong stakeholder networks with Regional Product Development, Global DTO, R&D Quality Management, P&S Quality Management, Operating Unit quality business partners and with projects such as MINT and One Biology
Qualifications for quality process manager
- BA/BS degree in Business, Finance, IT, or related field
- Excellent PC skills including application development experience within a Microsoft Office environment using Microsoft Excel and Microsoft Access
- Demonstrated ability to manage projects from start to finish (1-3 years’ experience)
- Ability to Analyze, track and publish performance results
- Six Sigma Certification is a plus, but not required
- Collect and understand the business needs from NSkinH manufacturing sites working with the other Business Process Managers, integrating the GMP inputs and identifying leverage with Nestlé