18017 - QA Manager

Job description:

Qualitest, the World’s Leading AI-Powered Quality Engineering Company

At Qualitest we're all about ensuring everything runs smoothly, whether it's your business, technology, or operations. We leverage smart engineering-led practices and precise processes to maintain excellence in all that we do.

Our clients are the world’s top brands and our diverse global team of 8,000 employees, including 1,500 in Israel, collaborates with industry leaders in technology, finance, insurance, and beyond, making a significant impact in the world of technology.

We offer creative and flexible solutions to ensure the quality of your business operations, safeguarding your brand's reputation. We're proud to say we've been pushing the boundaries for over 25 years now, always striving for innovation and delivering exceptional service.

Ready to make a difference? Join our dynamic and forward-thinking team!

We are looking for an experienced QA Manager for an exciting and challenging position in our Pharma Division!

The Quality Manager will be responsible for implementing, maintaining, and improving the Commercial and Distribution Quality Management System (QMS). This includes ensuring compliance with ISO 9001, ISO 90003, and regulatory requirements, overseeing internal and external audits, and leading quality assurance initiatives. 

Responsibilities:

• Maintain and improve the site QMS in accordance with global quality and regulatory standards
• Lead and support internal audits and external audits conducted by regulatory bodies, including the Standards Institute.
• Enhance quality culture and foster cross-functional collaboration with key stakeholders.
• Manage QMS documentation, updates, and process improvements to align with global changes.
• Oversee QMS performance tracking, data analysis, and reporting to ensure compliance and effectiveness.
• Approve corrections, containment measures, and product/process changes with moderate to high complexity.
• Work with SAP (or equivalent ERP system) for procurement and development requirements (responsibility to be assigned as needed).
• Act as the Quality Management Representative for the site.
• Conduct internal audits related to quality management, development processes, sales & service, and warehouse operations.

Requirements:

• Bachelor’s degree in Engineering, Biology, Chemistry, or a related field.
• Minimum 5 years of relevant experience, including supervisory roles, and experience in a regulated industry (GMP/ISO 13485).
• Audit Experience: Internal/external audits, including third-party audits.
• Minimum 2 years of experience with ERP systems such as SAP or Oracle.
• Certifications: ISO 13485 Lead Auditor certification (preferred)
• Strong communication, decision-making, project management, negotiation, and leadership skills.

Why should you join us?

• Recognized among Israel's top 100 best places to work for, four years in a row
• Be part of a company that is a globally recognized leader in Quality Engineering
• Experience our team spirit, working with real people, and solving real challenges
• Work with Senior Specialists and Practice Experts
• Nurture your personal and professional growth through tailored career paths
• Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
• Enjoy unique placement opportunities worldwide
• We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential

Qualitest, the World’s Leading AI-Powered Quality Engineering Company

At Qualitest we're all about ensuring everything runs smoothly, whether it's your business, technology, or operations. We leverage smart engineering-led practices and precise processes to maintain excellence in all that we do.

Our clients are the world’s top brands and our diverse global team of 8,000 employees, including 1,500 in Israel, collaborates with industry leaders in technology, finance, insurance, and beyond, making a significant impact in the world of technology.

We offer creative and flexible solutions to ensure the quality of your business operations, safeguarding your brand's reputation. We're proud to say we've been pushing the boundaries for over 25 years now, always striving for innovation and delivering exceptional service.

Ready to make a difference? Join our dynamic and forward-thinking team!

We are looking for an experienced QA Manager for an exciting and challenging position in our Pharma Division!

The Quality Manager will be responsible for implementing, maintaining, and improving the Commercial and Distribution Quality Management System (QMS). This includes ensuring compliance with ISO 9001, ISO 90003, and regulatory requirements, overseeing internal and external audits, and leading quality assurance initiatives. 

Responsibilities:

• Maintain and improve the site QMS in accordance with global quality and regulatory standards
• Lead and support internal audits and external audits conducted by regulatory bodies, including the Standards Institute.
• Enhance quality culture and foster cross-functional collaboration with key stakeholders.
• Manage QMS documentation, updates, and process improvements to align with global changes.
• Oversee QMS performance tracking, data analysis, and reporting to ensure compliance and effectiveness.
• Approve corrections, containment measures, and product/process changes with moderate to high complexity.
• Work with SAP (or equivalent ERP system) for procurement and development requirements (responsibility to be assigned as needed).
• Act as the Quality Management Representative for the site.
• Conduct internal audits related to quality management, development processes, sales & service, and warehouse operations.

Requirements:

• Bachelor’s degree in Engineering, Biology, Chemistry, or a related field.
• Minimum 5 years of relevant experience, including supervisory roles, and experience in a regulated industry (GMP/ISO 13485).
• Audit Experience: Internal/external audits, including third-party audits.
• Minimum 2 years of experience with ERP systems such as SAP or Oracle.

Why should you join us?

• Recognized among Israel's top 100 best places to work for, four years in a row
• Be part of a company that is a globally recognized leader in Quality Engineering
• Experience our team spirit, working with real people, and solving real challenges
• Work with Senior Specialists and Practice Experts
• Nurture your personal and professional growth through tailored career paths
• Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
• Enjoy unique placement opportunities worldwide
• We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential

Qualitest, the World’s Leading AI-Powered Quality Engineering Company

At Qualitest we're all about ensuring everything runs smoothly, whether it's your business, technology, or operations. We leverage smart engineering-led practices and precise processes to maintain excellence in all that we do.

Our clients are the world’s top brands and our diverse global team of 8,000 employees, including 1,500 in Israel, collaborates with industry leaders in technology, finance, insurance, and beyond, making a significant impact in the world of technology.

We offer creative and flexible solutions to ensure the quality of your business operations, safeguarding your brand's reputation. We're proud to say we've been pushing the boundaries for over 25 years now, always striving for innovation and delivering exceptional service.

Ready to make a difference? Join our dynamic and forward-thinking team!

We are looking for an experienced QA Manager for an exciting and challenging position in our Pharma Division!

The Quality Manager will be responsible for implementing, maintaining, and improving the Commercial and Distribution Quality Management System (QMS). This includes ensuring compliance with ISO 9001, ISO 90003, and regulatory requirements, overseeing internal and external audits, and leading quality assurance initiatives. 

Responsibilities:

• Maintain and improve the site QMS in accordance with global quality and regulatory standards
• Lead and support internal audits and external audits conducted by regulatory bodies, including the Standards Institute.
• Enhance quality culture and foster cross-functional collaboration with key stakeholders.
• Manage QMS documentation, updates, and process improvements to align with global changes.
• Oversee QMS performance tracking, data analysis, and reporting to ensure compliance and effectiveness.
• Approve corrections, containment measures, and product/process changes with moderate to high complexity.
• Work with SAP (or equivalent ERP system) for procurement and development requirements (responsibility to be assigned as needed).
• Act as the Quality Management Representative for the site.
• Conduct internal audits related to quality management, development processes, sales & service, and warehouse operations.

Requirements:

• Bachelor’s degree in Engineering, Biology, Chemistry, or a related field.
• Minimum 5 years of relevant experience, including supervisory roles, and experience in a regulated industry (GMP/ISO 13485).
• Audit Experience: Internal/external audits, including third-party audits.
• Minimum 2 years of experience with ERP systems such as SAP or Oracle.

Why should you join us?

• Recognized among Israel's top 100 best places to work for, four years in a row
• Be part of a company that is a globally recognized leader in Quality Engineering
• Experience our team spirit, working with real people, and solving real challenges
• Work with Senior Specialists and Practice Experts
• Nurture your personal and professional growth through tailored career paths
• Dive into interesting projects using cutting-edge technology designed by and for Quality Engineers
• Enjoy unique placement opportunities worldwide
• We believe in a workplace culture that values open communication and fairness, encouraging our employees to feel seen, supported, and empowered to realize their full potential