Manufacturing Quality Job Description
Manufacturing quality
provides training to new employees and to the site on key Quality processes, GMP & ISO standards.
Manufacturing Quality Duties & Responsibilities
To write an effective manufacturing quality job description, begin by listing detailed duties, responsibilities and expectations. We have included manufacturing quality job description templates that you can modify and use.
Sample responsibilities for this position include:
Control of Change-appropriate processes and systems are in place for the management of change with potential impact on quality and compliance
Auditing (Internal/External)–appropriate processes and systems in place to effectively manage (before, during, and follow up) GxP audits of facilities and operations
Deviations/CAPA-appropriate processes and systems in place to effectively manage deviations and related CAPAs
The position will review internal processes and procedures using data-driven problem analysis tools to fix operating issues and reduce cost of Quality & Failure for on-going projects
Co-ordinate the non-conformance, stop ship and rework processes in BCII
Quality tools & method innovation
Provide solutions to customer’s complaint through statistical and Quality tools
Implement, develop, and improve processes
Ensure quality processes
Establish appropriate Global manufacturing strategies for Coca-Cola Freestyle Equipment to meet quality, On Time Delivery, cost and business objectives
Manufacturing Quality Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Manufacturing Quality
List any licenses or certifications required by the position: ISO, ASQ, 9001, CQE, ASQC, DAWIA, ISO9001, AS9100, SQF, HACCP
Education for Manufacturing Quality
Typically a job would require a certain level of education.
Employers hiring for the manufacturing quality job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Technical, Manufacturing, Science, Mechanical Engineering, Industrial, Education, Electrical Engineering, Industrial Engineering, Management
Skills for Manufacturing Quality
Desired skills for manufacturing quality include:
Supplier management
General manufacturing operations
Mechanical quality and reliability concepts
ISO9001/ISO13485
GD&T
FDA and GMP requirements
Processes
Quality tools
GMP`s and ISO standards
Ms Word & Excel
Desired experience for manufacturing quality includes:
To take quality lead and coordination in local manufacturing projects implementation for MDD and LifeScan
Ensuring that all respective Russian External Manufacturers are maintaining an appropriate QMS and are compliant with applicable J&J Quality Policies, Standards, SOPs and EU GMP
Ensuring that activities of all respective Russian External Manufacturers are compliant and consistent with applicable J&J Quality Policies, Standards, SOPs and EU GMP
Supporting all respective Russian External Manufacturers to help them meet their quality and compliance objectives aligned with applicable J&J Quality Policies, Standards, SOPs and EU GMP
Assisting Russian External Manufacturers during audits, helping them in establishment of adequate CAPAs and follow up on CAPA execution
Assisting Russian External Manufacturers in handling of deviations, CAPAs and Change Control related to MDD and LifeScan localized products
Manufacturing Quality Examples
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Manufacturing Quality Job Description
Job Description Example
Our innovative and growing company is looking for a manufacturing quality. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manufacturing quality
- Utilize statistical methods in analyzing manufacturing operations quality issues and establishing quality standards, including performing capability studies on processes/equipment
- Provide statistical support (DOE, PFMEA, Mistake Proofing) during the development of new products and processes
- Manage and maintain the Company’s quality control processes and inspections for product realization
- Follow up on supplier qualification process of Russian External Manufacturers in relation to MDD and LifeScan localized products including packaging components and other related items
- Assisting Russian External Manufacturers in validation activities related to MDD and LifeScan localized products including packaging validation, shipping validation, route verification
- To make local product release for MDD and LifeScan
- Documentation - that GxP process documents are prepared, reviewed, approved, implemented, updated and retained, including archived/deleted, appropriately with the major focus on batch records for MDD and LifeScan localized products
- Continuous Improvement-a programme of continuous improvement across the GxP areas to ensure product of high quality and compliance
- Provides departmental resources in support of part conformities, new STC activity, (30%)
- Performs administrative tasks such as regulatory research, PMA supplement submissions, training, (15%)
Qualifications for manufacturing quality
- Excellent interpersonal, collaboration, networking and communication skills, self-motivated, clear thinker
- Influence, leadership and ability to effectively operate at executive / board level, including assertiveness in conflict/challenging situations
- Fluent English - Upper intermediate and higher level
- Readiness for business tripsQuality (Eng)
- Minimum of 1-3 years’ experience in a manufacturing inspector role
- Positions are full-time with either first or second shifts including overtime and weekend work if needed
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Manufacturing Quality Job Description
Job Description Example
Our company is looking for a manufacturing quality. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for manufacturing quality
- Compiles and reviews Manufacturing executed and pre-executed batch records in accordance with cGMP and internal procedures in an efficient and timely manner
- Compiles and reviews raw data and batch records in accordance with cGMP, Code of Federal Regulations (CFR), Points to Consider (PTC) guidelines and internal procedures in an efficient and timely manner
- Maintains awareness of activities by routine direct observation of Cell Production suites and facility
- Reviews and approves Non-conforming events (NCE)
- Participates as needed to support internal and/or client audits
- Trains personnel on job functions and responsibilities and participates in area training coordinator responsibilities
- Verifies and releases shipments of finished product or cell bank vials to clients or contract labs
- Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks
- Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines
- Leads/supports Client audits of the facility
Qualifications for manufacturing quality
- Proficient with computer equipment and software programs such as SAP, MS Outlook
- Supports routine GMP and Pre-Approval Inspection regulatory audits
- Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness
- Conducts and confirms follow-up actions on Corporate, Client, Internal, and Regulatory site compliance audits/inspections
- Bachelor's degree required, preferably in a scientific or technical discipline
- Minimum 3 years’ experience in the pharmaceutical/biotech or other regulated industry, medical device, foods, automotive
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Manufacturing Quality Job Description
Job Description Example
Our company is growing rapidly and is looking for a manufacturing quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing quality
- Utilizes control charts and other quality tools to make improvement decisions
- Builds strong collaboration and partnership with each Business Unit
- Responsible for implementation of RP Quality Strategy Initiatives
- Lead/Support project team leaders in cost competitive and manufacturing optimization projects to achieve business unit objectives and financial targets
- Lead multiple facilities effort to eliminate product and process defect causes by utilizing Team-Oriented Problem Solving methodology and recommending changes or solutions to problems
- Lead the development of “Systemic Analysis of Root Causes” determined during the problem solving process
- Ensure that the manufacturing sites are developing, deploying and maintaining compliance to ISO/TS 16949 and/or successor standards, Customer Specific Requirements, VDA requirements and other industry standards
- Ownership of the business units Internal Performance Metrics Scorecard system
- Lead the development of a Quality culture that achieves Zero PPM and Zero Customer Complaints performance mindset
- Lead manufacturing improvement projects associated with Inter plant supplies, including managing inter plant product launch issues
Qualifications for manufacturing quality
- Working understanding of server subcomponents (HDD, SSD, memory, mother board, power, thermal, peripherals)
- 3+ years experience in GMP pharmaceutical / FMCG manufacturing environment in the area of quality management systems / quality assurance / quality control
- Relevant university degree or business experience and qualifications in areas applying process methodologies
- Experience in Process and Product Engineering as a plus
- Ability to proactive communication at mid level / top level management at pharmaceutical plant
- Continuous development into current GxP regulations, guidelines and industry quality standards
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Manufacturing Quality Job Description
Job Description Example
Our company is looking to fill the role of manufacturing quality. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for manufacturing quality
- Support the development of world class Supply Chain quality procedures and processes and ensure that suppliers are in compliance as defined by the Quality Management System
- Proven experience driving improvements in supplier quality performance, processes, or designs through an ME, process or engineering discipline
- Good experience of purchasing procedures and processes including purchase order control, supplier portals, FAIR, Non-conformance management and PAPP
- Knowledge of industry wide processes associated with AS9100, AS9102, EASA Part 21G and NADCAP
- Develop Quality professionals and direct their training, quality functional competency development activities to drive enhanced levels of quality teams performance in achieving business objectives
- Drive the development of quality related policy deployment objectives
- Lead the effort in reducing defects by 50% year over year
- Lead the review/assessment of customer complaints or field failures, providing solutions as appropriate to eliminate the recurrence of the issue (specifically Out of Box failures)
- Manage ISO system and certification requirements for North American Operations
- Assist Supplier Quality Engineering to ensure vendor quality/provide technical support to suppliers
Qualifications for manufacturing quality
- Previous auditing experience preferred
- Must be able to gown qualify for Grade C/D production areas
- Application of problem solving tools and techniques including 8D, 5 why, Fish bone, DMAIC, SPC
- Minimum 8 years' Quality experience in automotive manufacturing environment
- He or she will provide advanced expertise in Trackwise and taking a leadership role in investigating and writing Manufacturing Deviations, CAPAs and Effectiveness Checks
- MFG Quality Specialist will focus on future improvements and the ability to strategically plan for future Quality & Compliance Systems changes to meet future changes in Technical Operations
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Manufacturing Quality Job Description
Job Description Example
Our growing company is hiring for a manufacturing quality. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for manufacturing quality
- Set up and coordinate and/or facilitate improvement project teams
- Develop and provide “expert” level knowledge and training in six sigma tools and strategies
- Monitor and report on quality metrics and progress toward quality goals including, Rolled Throughput Yield (RTY), Warranty Failures, and Out of Box (OOB) Failures
- Recommend test and inspection equipment as required achieving quality goals
- Act as a spokesperson for quality initiatives to generate understanding and support throughout the facility
- Liaison with Engineering and New Product Implementation (NPI) teams on design for manufacturability, quality and reliability
- Assist management and teams in selecting quality measures and setting up quality reporting systems
- Evaluate results data for improvement opportunities
- All Levels of Management
- Organize and manage a portion of the quality assurance function in close cooperation with the Quality Manager
Qualifications for manufacturing quality
- Superior business acumen, technical knowledge, and industry experience encompassing quality management domains
- The MFG Quality Specialist will also have direct oversight and involvement of GMP Facility cleaning operations and gowning management
- Involvement may include but is not limited to participating in cleaning audits, review of cleaning forms and coordination of cleaning activities
- Lead investigations & ownership of Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
- Timely closure (within 30 days for Deviations, QEs) is a critical aspect of this responsibility
- The MFG Quality Specialist will also act as a coordinator for other deviations within the department, to take a larger role for department compliance