Cambridge, Cambridgeshire, United Kingdom
As a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.
Our quality and regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence with strategic and operational plans.
As our Supplier Quality Engineer, you will provide support to the Global Supplier Quality organization dedicated to the oversight of suppliers. Your technical knowledge and expertise will enable you to work across the organization to ensure suppliers can meet all requirements.
What To Expect
Execute all applicable activities to comply with regulatory standards and meet the requirements established in the Quality Management System around supplier’s quality management.
In liaison with R&D and Product Engineering teams,
conduct technical reviews on suppliers to understand their capability to make materials. Assist in
assessing and monitoring suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection.” Assist technical teams in defining and approving
PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion. Work along with suppliers to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development, Product Engineering and Design Assurance. Liaise with internal teams to issue and follow up on Agile Quality figures
called “SCARs” and “SACAs” and “NCEs” related to suppliers’ performance. Work collaboratively with suppliers and internal teams (R&D, Product Engineering) on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution. Work with Quality and Regulatory and other applicable departments (Product Engineering, Research and Development, etc.) to address complaints linked to suppliers for inclusion into the Post market Surveillance process. Assist in resolving quality day to day issues associated with suppliers
around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted raw material (return to supplier, rework, sort, etc.). Work with Quality department to approve and maintain performance oversight of suppliers. Assist in maintaining complete supplier quality records
as per the applicable procedure (e.g., supplier performance key indicators, supplier’s quality certifications, etc.). Update suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met. Support supplier audits. Travel might be required. Work with Supply Chain to update the ERP system
with the status of the approved suppliers for the materials. As applicable, attend to functional and departmental meetings and follow up on action items accordingly. Assist in coordinating/executing the change in specifications
and/or procedures when required through the corresponding change order. Ensure training has been completed
in the respective procedures in the training system, before executing the respective task. Maintain up to date training records. If applicable, generate supplier performance metrics
to be used in decision making. Provide the necessary reports to the stakeholders. Coordinate Periodic Quality Review meetings with suppliers that require it, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out. Work with stakeholders and assist in coordinating and executing activities
related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the component’s suppliers comply with the requirements stipulated in the quality system before the closure of the projects. Assist in the qualification of new suppliers
and/or new parts/components of an already approved supplier. Perform other duties as required by his/her supervisor/manager. What We Expect Expertise:
Bachelor’s degree preferred in Bachelor related Engineering/microbiology career. Knowledge:
ASQ Supplier Quality Engineer Certificate, Project Management Techniques, Major Medical Device Regulations, cGMP, CFR 820, MDR 2017/745, MDSAP, ISO-13485, ISO-14971, ISO-9001. Autonomy:
Must be able to work independently and with all levels of the organization. Communication:
Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations. Agility:
Ability to handle and manage multiple complex projects. Flexibility to adapt to changing market conditions, requirements, and company priorities. Skills:
Validations and root cause analysis, Proficiency with eQMS software. Collaborative:
Works well with team members and internal teams globally. Proactive:
Ability to anticipate challenges and take initiative to address them. Resilience:
Maintains a positive attitude and strong work ethic even in challenging situations. Continuous Learning:
A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviors. Experience:
10 or more years of experience in medical device manufacturing or related industry. 5 or more years of experience in diagnostics/microbiology (preferable). Problem Solving:
Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes. Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan. Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. Our talent partners can discuss our salary offering and any relevant bonus schemes with you.
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conduct technical reviews on suppliers to understand their capability to make materials. Assist in
assessing and monitoring suppliers making parts as it relates to manufacturing, process and quality control practices, corrective action, continuous improvement, and “First Article Inspection.” Assist technical teams in defining and approving
PPAP (Production Part Approval Process) requirements for all new and revised purchased parts (as applicable). Follow up for their on-time completion. Work along with suppliers to exceed the “fit, form and function” and reliability requirements, while working internally with Research & Development, Product Engineering and Design Assurance. Liaise with internal teams to issue and follow up on Agile Quality figures
called “SCARs” and “SACAs” and “NCEs” related to suppliers’ performance. Work collaboratively with suppliers and internal teams (R&D, Product Engineering) on problem solving and root cause analysis to avoid repeat failures. Apply (as applicable), metrology and statistical measurement to problem analysis and resolution. Work with Quality and Regulatory and other applicable departments (Product Engineering, Research and Development, etc.) to address complaints linked to suppliers for inclusion into the Post market Surveillance process. Assist in resolving quality day to day issues associated with suppliers
around the globe by addressing non-conformities: call into containment and work along with the corresponding departments to achieve disposition of the impacted raw material (return to supplier, rework, sort, etc.). Work with Quality department to approve and maintain performance oversight of suppliers. Assist in maintaining complete supplier quality records
as per the applicable procedure (e.g., supplier performance key indicators, supplier’s quality certifications, etc.). Update suppliers’ files when required and check that the information is accurate and complete, assuring that all applicable regulatory standards are met. Support supplier audits. Travel might be required. Work with Supply Chain to update the ERP system
with the status of the approved suppliers for the materials. As applicable, attend to functional and departmental meetings and follow up on action items accordingly. Assist in coordinating/executing the change in specifications
and/or procedures when required through the corresponding change order. Ensure training has been completed
in the respective procedures in the training system, before executing the respective task. Maintain up to date training records. If applicable, generate supplier performance metrics
to be used in decision making. Provide the necessary reports to the stakeholders. Coordinate Periodic Quality Review meetings with suppliers that require it, as well as follow up on the activities agreed upon in these meetings to ensure that they are carried out. Work with stakeholders and assist in coordinating and executing activities
related to the implementation of new suppliers as a result of the introduction of new products, transfer of products, alternate suppliers, etc.; ensuring that the component’s suppliers comply with the requirements stipulated in the quality system before the closure of the projects. Assist in the qualification of new suppliers
and/or new parts/components of an already approved supplier. Perform other duties as required by his/her supervisor/manager. What We Expect Expertise:
Bachelor’s degree preferred in Bachelor related Engineering/microbiology career. Knowledge:
ASQ Supplier Quality Engineer Certificate, Project Management Techniques, Major Medical Device Regulations, cGMP, CFR 820, MDR 2017/745, MDSAP, ISO-13485, ISO-14971, ISO-9001. Autonomy:
Must be able to work independently and with all levels of the organization. Communication:
Ability to effectively communicate ideas and approaches in the form of proposals, plans and presentations. Agility:
Ability to handle and manage multiple complex projects. Flexibility to adapt to changing market conditions, requirements, and company priorities. Skills:
Validations and root cause analysis, Proficiency with eQMS software. Collaborative:
Works well with team members and internal teams globally. Proactive:
Ability to anticipate challenges and take initiative to address them. Resilience:
Maintains a positive attitude and strong work ethic even in challenging situations. Continuous Learning:
A commitment to ongoing professional development and staying abreast of industry trends and advancements. Embraces and encourages learning new skills, knowledge and behaviors. Experience:
10 or more years of experience in medical device manufacturing or related industry. 5 or more years of experience in diagnostics/microbiology (preferable). Problem Solving:
Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes. Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan. Why Hologic? We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. Our talent partners can discuss our salary offering and any relevant bonus schemes with you.
#J-18808-Ljbffr
