QMS Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
Part of the End 2 End program, the Quality System Business Process Expert supports the development, deployment and maintenance of the Quality Management System within the company's Healthcare division, ensuring the company's cross sector harmonization, standardization and regulatory compliance.
You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.
Your team
Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate.
• Validation Business Process Expert, acting in support of the the company's Healthcare Quality Assurance team and Q&R Business Process Owner, across the the company's Q&R network for the E2E program.
• Provide guidance, review and approval of validation deliverables including but not limited to tool Classification, Risk analysis, Part 11 assessment, Validation Plan, User Requirements Specification, Validation Summary Report, etc.
• Report on status to E2E Q&R and Project management.
• Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with PMS, prior to issuance.
• Participate directly as the company's Healthcare Quality Management System Business Process Expert in the validation of applications, in the company's Integrated Landscape. Ensuring compliance, efficiency and effectiveness of the processes within the company's Healthcare sector, cross sectors, and at the company's corporate.
• Support cross-the company's setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams.
• Minimum of 3-5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Skill set required for the department to operate:
o Thorough understanding of 21 CFR Part 11 & 21 CFR Part 820 and ability to translate this to IT requirements
o Thorough understanding of GAMP 5, V-model methodology and guidance documents: GPSV / AAMI TIR36.
o Thorough understanding of ISO 13485, ISO 14971, ISO 9001 and ability to translate this to IT requirements
o Hands on experience with end to end lifecycle of software validation ( Development , Operations/ Maintenance, Upgrade , Retirement)
o Good Understanding of SDLC, Agile and other development and project management methodologies
o Comfortable with working across time zones and seniority levels. Will need to be confident to provide guidance to teams.
o Project management experience, desired
o Good communication skills written & verbal in English
o Software validation experience: understanding of high-level view of the requirements and supporting processes.
o Demonstrated experience in collaborative working environments
o Experience addressing conflicts, escalation at team level to achieve desired results.
o Demonstrated experience handling deadlines, able to focus on targets
o Demonstrated experience-driving progress, taking initiative to achieve results.
o Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to
delivering products & service to the customers.
Desirable Skills
• Knowledge of 21 CFR Part 210 , 211
• Experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections
• Auditing experience, either in supporting or doing audits
• Awareness of Lean methodologies
What we are NOT looking for, are candidates with
• Only theoretical knowledge of regulations / guidelines
• Only task execution experience
• Only testing experience (Unit Testing, Module Testing, Integration Testing, System Testing , UAT , Black box testing etc.)
• Only regulatory affairs experience (such as PMA, 510(k) and other FDA submissions)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim de Jong.
The Company
The company you will be working for is based in Noord-Brabant, The Netherlands. It is one of the major players in the field of medical devices, and well-known throughout The Netherlands and abroad.Role Description
Your challengePart of the End 2 End program, the Quality System Business Process Expert supports the development, deployment and maintenance of the Quality Management System within the company's Healthcare division, ensuring the company's cross sector harmonization, standardization and regulatory compliance.
You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.
Your team
Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring Quality System Regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate.
Responsibilities
Provide Computer system Validation support to the E2E Program teams to ensure consistent compliance with optimization and efficiency in E2E processes.• Validation Business Process Expert, acting in support of the the company's Healthcare Quality Assurance team and Q&R Business Process Owner, across the the company's Q&R network for the E2E program.
• Provide guidance, review and approval of validation deliverables including but not limited to tool Classification, Risk analysis, Part 11 assessment, Validation Plan, User Requirements Specification, Validation Summary Report, etc.
• Report on status to E2E Q&R and Project management.
• Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process in compliance with PMS, prior to issuance.
• Participate directly as the company's Healthcare Quality Management System Business Process Expert in the validation of applications, in the company's Integrated Landscape. Ensuring compliance, efficiency and effectiveness of the processes within the company's Healthcare sector, cross sectors, and at the company's corporate.
• Support cross-the company's setup and deployment of the Quality Management Systems along business model lines as identified by End-to-End teams.
Requirements
• Bachelor’s degree or equivalent preferably in a technical or engineering or/and IT related field(s).• Minimum of 3-5 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
• A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
o This position requires an extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations.
• An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
• Skill set required for the department to operate:
o Thorough understanding of 21 CFR Part 11 & 21 CFR Part 820 and ability to translate this to IT requirements
o Thorough understanding of GAMP 5, V-model methodology and guidance documents: GPSV / AAMI TIR36.
o Thorough understanding of ISO 13485, ISO 14971, ISO 9001 and ability to translate this to IT requirements
o Hands on experience with end to end lifecycle of software validation ( Development , Operations/ Maintenance, Upgrade , Retirement)
o Good Understanding of SDLC, Agile and other development and project management methodologies
o Comfortable with working across time zones and seniority levels. Will need to be confident to provide guidance to teams.
o Project management experience, desired
o Good communication skills written & verbal in English
o Software validation experience: understanding of high-level view of the requirements and supporting processes.
o Demonstrated experience in collaborative working environments
o Experience addressing conflicts, escalation at team level to achieve desired results.
o Demonstrated experience handling deadlines, able to focus on targets
o Demonstrated experience-driving progress, taking initiative to achieve results.
o Experience understanding the process approach ‘End-to-End’, where, the optimization of customer value chain starts from ‘customer insight’ all the way to
delivering products & service to the customers.
Desirable Skills
• Knowledge of 21 CFR Part 210 , 211
• Experience in working directly with FDA/MHRA/ TGA/ ANVISA/other regulatory inspections
• Auditing experience, either in supporting or doing audits
• Awareness of Lean methodologies
What we are NOT looking for, are candidates with
• Only theoretical knowledge of regulations / guidelines
• Only task execution experience
• Only testing experience (Unit Testing, Module Testing, Integration Testing, System Testing , UAT , Black box testing etc.)
• Only regulatory affairs experience (such as PMA, 510(k) and other FDA submissions)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim de Jong.
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