Senior Technical Quality Engineer
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Roskilde
The job:
Are you an experienced Quality Engineer, and do you enjoy working with technical quality engineering? Then you might be the person we are looking for!
We are currently looking for a Senior Technical Quality Engineer to join us in this new established role. The position will also support our manufacturing sites in Denmark, Finland and the UK
As our new Senior Technical Quality Engineer, you will report to our Quality Director based in the US, and you’ll be part of our global Quality Operations team. This senior level position is responsible for the quality oversight of design control and risk management activities for Medical Devices and In Vitro Diagnostics.
In this role, you will work closely with product development teams and testing partners during the product design and development phases with supportive responsibilities throughout the product lifecycle.
In addition, this role will provide oversight for the development, implementation, and continuous improvement of product-related quality processes and procedures to ensure compliance to relevant standards and regulatory requirements.
What will you do?
• Ensure that appropriate quality plans are developed to include all stages of the life cycle of the product and supports Quality Plan design, product specifications, quality specifications and quality plans in conjunction with other product development team members
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and or product/system lifecycle
• Participate in new product introductions to ensure regulatory compliance through Validation & Verification
• Interface with appropriate customer contacts to clarify customer requirements
• Participate in pre- and post-production launch reviews providing quality engineering support
• Lead product sustaining Technical Quality (quality engineering) activities like: creating and/or overseeing the execution of Quality Plans, assessing complex product designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex quality problem solving.
• Assist with other quality engineering support, including supporting the business or site in leading the resolution of quality engineering deficiencies
• Review and approves technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applicable procedures and regulatory requirements
• Lead or support sustainable, continuous improvement of regulated products Quality Management System (Med Devices / In-vitro Diagnostics)
Who we are looking for:
• Education: Bachelor’s degree in Science or Engineering discipline
• Minimum 5 years of related experience, or a master’s degree with 3+ years of relevant experience
• Medical Device Design and Development experience
• Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, and ISO14971
• Project Management skills
• Statistical Analysis Tools such as Minitab or JM and experience with advanced data collection, measuring, analysis, improvement and control
• Must have organizational and interpersonal skills working in a cross-functional teams.
• Ability to organize and prioritize workflow in order to meet established time frames and schedules
About us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realize your best – professionally and personally.
Apply today!
http://jobs.thermofisher.com
Are you an experienced Quality Engineer, and do you enjoy working with technical quality engineering? Then you might be the person we are looking for!
We are currently looking for a Senior Technical Quality Engineer to join us in this new established role. The position will also support our manufacturing sites in Denmark, Finland and the UK
As our new Senior Technical Quality Engineer, you will report to our Quality Director based in the US, and you’ll be part of our global Quality Operations team. This senior level position is responsible for the quality oversight of design control and risk management activities for Medical Devices and In Vitro Diagnostics.
In this role, you will work closely with product development teams and testing partners during the product design and development phases with supportive responsibilities throughout the product lifecycle.
In addition, this role will provide oversight for the development, implementation, and continuous improvement of product-related quality processes and procedures to ensure compliance to relevant standards and regulatory requirements.
What will you do?
• Ensure that appropriate quality plans are developed to include all stages of the life cycle of the product and supports Quality Plan design, product specifications, quality specifications and quality plans in conjunction with other product development team members
• Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and or product/system lifecycle
• Participate in new product introductions to ensure regulatory compliance through Validation & Verification
• Interface with appropriate customer contacts to clarify customer requirements
• Participate in pre- and post-production launch reviews providing quality engineering support
• Lead product sustaining Technical Quality (quality engineering) activities like: creating and/or overseeing the execution of Quality Plans, assessing complex product designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex quality problem solving.
• Assist with other quality engineering support, including supporting the business or site in leading the resolution of quality engineering deficiencies
• Review and approves technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applicable procedures and regulatory requirements
• Lead or support sustainable, continuous improvement of regulated products Quality Management System (Med Devices / In-vitro Diagnostics)
Who we are looking for:
• Education: Bachelor’s degree in Science or Engineering discipline
• Minimum 5 years of related experience, or a master’s degree with 3+ years of relevant experience
• Medical Device Design and Development experience
• Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, and ISO14971
• Project Management skills
• Statistical Analysis Tools such as Minitab or JM and experience with advanced data collection, measuring, analysis, improvement and control
• Must have organizational and interpersonal skills working in a cross-functional teams.
• Ability to organize and prioritize workflow in order to meet established time frames and schedules
About us:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon
With Thermo Fisher Scientific, it’s not just a career. It’s a chance to realize your best – professionally and personally.
Apply today!
http://jobs.thermofisher.com
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Roskilde.
Jobbet er oprettet på vores service den 19.8.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- Roskilde
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