Quality Engineer - Medical Device

Job description

·  East Walpole, Massachusetts
·  Quality Management
·  238403
Siemens Healthineers

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Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 238403
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Division Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

Job Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

Now's our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

Join our team now at Siemens Healthineers asa Quality Engineer 4 .

Position Overview
Are you ready to be part of a dynamic Medical Device Company that delivers quality, compliant, and timely diagnostics testing consumables to customers worldwide? This Quality Professional (QA) position reports to the Sr. Manager of Quality and provides daily support to the cross functional operations at the East Walpole site across three business units which include Immunoassay, Point of Care, and Molecular Diagnostics. This position primarily manages Quality Notifications and provides Batch Release of Reagents for Atellica & Centaur Assays, in addition to supporting these activities during new platform launch. Secondary responsibilities are quality document approvals and audit support.

This is a role well suited to an ambitious Quality Assurance – Quality Professional, looking for the next step in their career. As a Quality Engineer 4 , you will be responsible for :

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Ensuring site strategies and procedures are adhered to and in alignment with Global Procedures to ensure compliance with US and International standards applicable to In Vitro diagnostics. Such standards include; 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and European IVDD Directive 98/79/EC.

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Leading Quality Initiatives to drive quality system improvements.

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Fostering trust, collaboration and cooperation with manufacturing teams when resolving discrepancies and non-conformance events.

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Supporting investigations and resolutions of manufacturing issues while ensuring that communication is effective and information is provided in a timely manner and decisions are compliant.

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Driving the Quality Notification process for product disposition and release.

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Reviewing and approving Device History Records for final QA batch release.

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Managing on site cross functional compliance walk throughs to ensure facility is continuously audit ready; Supporting Notified Body and Regulatory Audit preparations and provides a key role during on site audits.

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Providing QA review and approval on documents and technical reports to support site Change Control projects.

Desired Knowledge/ Skills/ Experience:
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Working knowledge of the IVDD Directive 98/79/EC is highly desirable

Required Knowledge/Skills and Experience to have for the success of this role

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Education: Bachelor's degree in biology, chemistry, or another scientific discipline. Other educational experience will be considered in conjunction with work experience.

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Experience: A minimum of 8 years of experience in either the medical device or pharmaceutical/biotech industry, with a minimum of 3 years in a quality role.

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Requires a proven understanding of external regulations, particularly with regards to 21 CFR Part 820 and ISO 13485.

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Strong oral and written communication skills and adept at establishing interpersonal relationships.

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Proven ability to work in a team environment, balancing compliance risk with business need.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers .

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about .

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more,Click here .

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more,Click here .

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