JOB DESCRIPTION:
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has more than 4,000 employees working in manufacturing, research and development, logistics, manufacturing, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Cologne, Jena and Hamburg.
Working at Abbott
At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:
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Career development with an international company where you can grow the career you dream of
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An attractive benefits package (e.g. attractive Abbott Pension Plan, a company bike, employee stock purchase program)
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A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
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A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
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A challenging position in a fast-growing crisis independent industry
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To become part of a dynamic, highly educated, highly skilled, and motivated team
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Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
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Multi-national environment, where we foster the development of our talents within the enterprise
Abbott Automation Solutions GmbH in Hamburg has an opportunity for a Design Quality Engineer, Hardware (m/f/d).
WHAT YOU’LL DO
Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity in the Medical Device space. It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to hardware product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.
Main Responsibilities:
Responsible for implementing and maintaining the effectiveness of the quality system.
- Design/Change Control - Hardware responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
- Engineering Drawings - Review & approve engineering drawings, part structure and associated metadata in our PDM Tool. It is expected to have a firm understanding of engineering drawings and the knowledge of PDM “Product Data Management” tools. Effective navigation & facilitation of these processes and tools is paramount to ensuring efficient review & approval of parts/assemblies.
- Risk Management - Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
- Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
- Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
- Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
- Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
- Quality Engineering - Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
- B.S. in Mechanical Engineering; Electrical Engineering; Biomedical Engineering; Life Science or closely related discipline is required or relevant combination of education & experience.
- Minimum 2 years’ experience.
- Engineering experience and demonstrated use of Quality tools/methodologies.
- Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971 is a plus
- Solid communication and interpersonal skills.
- Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.
Connect with us at www.abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:CRLB Core Lab
LOCATION:Germany > Hamburg : Sachsenkamp 5
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
Top Skills
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
