Quality Professional 3

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 as a Quality Professional 3.

This position includes the handling of all types of materials, including hazardous and DEA (Drug Enforcement Agency) controlled materials.

This position will support Corrective and Preventive Action (CAPA) and Internal Audit processes at the Walpole site. Additionally, this position will play a key role in external audit activities, as well as serve as a back-up for the Quality Assurance batch release process.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Quality Professional 3, you will be responsible for: 


• Review of CAPA records, data forms, and other associated documentation. Help to identify discrepancies and work to obtain resolution of the discrepancies with the responsible individual(s).
• Keep minutes CARB meetings and track CARB actions items.
• Assist in the generation and tracking of CAPA metrics/KPIs
• Serve as the Walpole site back-up for the CARB Chair
• Assist in the maintenance the CATSWeb CAPA tool
• Provide support to site CAPA users both on the CATSWeb tool and CAPA process
• Manage the Issue Resolution (IR) process

Internal Audits:
• Lead quality systems audits
• Coordinate audits by external consultant

• Track internal audit completion/progress
• Track internal audit metrics/KPIs
• Maintain internal auditor credentials

External Audits:

  • Support audit preparation and audit follow-up activities
  • Participate in audit backroom
  • Act as a back-up for the QA batch release process, as well as support various quality system initiatives.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers.  Preferred Knowledge, Skills and Experience:

• Experience with FDA and/or notified body audits
• ASQ Certified Quality Auditor (CQA) certification
• ASQ Certified Quality Engineer (CQE) certification

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

• BS in Biology, Chemistry, Engineering or related discipline with a minimum of 5 years of experience in the medical device or biotechnology industry
• Strong working knowledge of FDA Quality System Regulation (QSR) and ISO 13485 requirements particularly in the area of CAPA
• Experience participating on multifunctional teams
• Experience performing internal audits
• Demonstrated ability to interact professionally and positively with employees at all levels of the organization.
• Possess an excellent attention to detail
• Possess excellent written/verbal communication skills
• Competent with Microsoft Office suite (Excel, Word, Outlook, etc.)

Must pass a Drug Enforcement Agency (DEA) background check.

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.

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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 unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, 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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