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 newly created role. The position will be based at our production site in Roskilde, Denmark.
As our new Senior Technical Quality Engineer, you’ll report to our Quality Director based in the US, and you’ll be part of our Quality Operations team, and you will play a critical role in managing system quality (quality system, product quality, and solution quality and risk management) throughout the product life cycle.
What will you do?
• Creation/Update technical documentation (labelling, packaging) according to FDA/ MDR/IVDR, assess changes and update DHF (traceability matrix)
• DHF Remediation and sustaining activities
• Ensures 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
• Drives the validation of key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and or product/system lifecycle
• Participates in new product introductions to ensure regulatory compliance through Validation & Verification
• Interfaces with appropriate customer contacts to clarify customer requirements
• Participates in pre- and post-production launch reviews providing quality engineering support
• Leads 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.
• Assists with other quality engineering support, including supporting the business or site in leading the resolution of quality engineering deficiencies.
• Drives resolution of complex issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Sustains product documentation to ensure compliance
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
• 3+ years’ experience in Quality Engineering, including quality systems, standards, metrics, and tools
• ASQ certification as Certified Quality Engineer preferred
• Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, and ISO14971
• 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
• Statistical Analysis Tools such as Minitab or JM and experience with advanced data collection, measuring, analysis, improvement and control
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 Scientic, it’s not just a career. It’s a chance to realise 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 newly created role. The position will be based at our production site in Roskilde, Denmark.
As our new Senior Technical Quality Engineer, you’ll report to our Quality Director based in the US, and you’ll be part of our Quality Operations team, and you will play a critical role in managing system quality (quality system, product quality, and solution quality and risk management) throughout the product life cycle.
What will you do?
• Creation/Update technical documentation (labelling, packaging) according to FDA/ MDR/IVDR, assess changes and update DHF (traceability matrix)
• DHF Remediation and sustaining activities
• Ensures 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
• Drives the validation of key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides effective oversight of the execution of the Quality Plan, any Risk Management activities, and or product/system lifecycle
• Participates in new product introductions to ensure regulatory compliance through Validation & Verification
• Interfaces with appropriate customer contacts to clarify customer requirements
• Participates in pre- and post-production launch reviews providing quality engineering support
• Leads 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.
• Assists with other quality engineering support, including supporting the business or site in leading the resolution of quality engineering deficiencies.
• Drives resolution of complex issues where analysis of situations or data requires an in-depth knowledge of organizational objectives.
• Sustains product documentation to ensure compliance
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
• 3+ years’ experience in Quality Engineering, including quality systems, standards, metrics, and tools
• ASQ certification as Certified Quality Engineer preferred
• Working knowledge of medical device regulations (FDA 21CFR80.820, FDA 21 CRF Part 11, ISO13485, ISO10993, and ISO14971
• 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
• Statistical Analysis Tools such as Minitab or JM and experience with advanced data collection, measuring, analysis, improvement and control
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 Scientic, it’s not just a career. It’s a chance to realise 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 2.3.2021, 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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| Dato | Alle jobs som produktspecialister |
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