Quality Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

This position has a hybrid schedule (3 days onsite and 2 days remote) and based at our Knoxville, TN office.

As a CMO Support Quality Specialist, you will be responsible for:

• The support and facilitation of site audits by drug sponsors including gathering/organizing requested information and responding to observations.

• The support of investigations in conjunction with the manufacturing site and/or drug sponsor.

• Facilitating communication and approval for exceptions, planned variances, change controls, etc.

• Managing quality system metric reporting for drug sponsor products.

• Facilitating and leading meetings with drug sponsors (i.e., routine meetings, quality reviews, etc.).

• Ensure compliance with regulatory changes, drug sponsor expectations, and patient/product safety.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

• You have 5 years of experience in the sterile injectable pharmaceutical industry.

• You have CMO relationship management.

• You have knowledge of 21 CFR 211 regulations and associated sterility assurance guidance documents.

• You have an understanding of the drug development process

• Experience with MS Office: Word, PowerPoint, Excel and Outlook.

• You are willing to travel and are flexible in responding to changing project priorities.

Required skills to have for the success of this role

• BS/MS in a scientific discipline.  A degree in Microbiology is preferred.

• Minimum of 5 years of experience in Quality Assurance in the sterile injectable pharmaceutical industry. 

• You have 2 years of experience with cleanroom qualifications and/or design.

• Prior experience authoring FDA audit responses.

• Flexible in responding to changing project priorities.

• Flexibility to work on issues of diverse scope and apply knowledge gained to multiple tasks.

• Exercise good judgment in decision-making and sharing of sensitive information.

• Ability to meet strict timelines.

• Attention to detail and accuracy.

• Willing to travel up to 20%.

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$107,060 - $147,213

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

Equal Employment Opportunity Statement: Siemens Healthineers