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The qualified candidate will work as a member of the Manufacturing Quality Assurance group at the Mishawaka, IN site. As the new site quality engineer this individual will use their leadership skills to drive improvements in the site quality management function and collaborate with the site Head of Quality in ensuring the site maintains compliance to MDSAP, FDA, and ISO Quality Management Systems for medical devices to provide quality engineering support for manufacturing, ensure that the quality of supplied materials is maintained and meets specification requirements, drive supplier corrective actions to resolution, create quality initiatives for reducing in- process/finished goods scrap, and transfer analog processes to digital platforms. 

Key responsibilities 

This person provides on call response to any manufacturing quality questions/concerns for all shifts.  They will support the manufacturing manager and line supervisors in decision making for nonconforming finished goods.  They will support decision making on whether to stop the line purge the product and scrap or continue to run and use as is. 

Support Manufacturing 

Provide quality engineering help w/ mfg. line problem resolution 

Support the engineering team on decision making when there are equipment breakdowns that lead to product quality decisions and line down time. 

Drive process control and monitoring improvement 

Drive manufacturing process improvement activities to improve outgoing product quality, e.g. scrap reduction, SPC, improved test methods…etc. 

Support Process Validation activities 

Maintain mfg. compliance with regulatory requirements 

Provide operator training for new testing requirements 

Primary point to resolve QNs 

Perform CAPA root cause investigations and are assigned as lead investigators for nonconformances identified in manufacturing process. 

Site representative for label reviews and first article inspections 

Develop and maintain Process Control   

Every key manufacturing process should have a robust process control and monitoring plan that is driven as an output from the process validation. 

Continual monitoring of process controls to drive improvement. 

Supplier Quality 

Ensure that the quality of supplied materials is maintained and meets specification requirements 

Perform supplier quality audits as assigned 

Drive supplier corrective actions to resolution 

Education and Qualifications:  

The successful candidate will possess a B.S. in science/engineering (preferred).  The candidate will have at least 5 years of experience in Quality Assurance/Control Engineering, quality engineering role at a medical device facility, and successful demonstration of key responsibilities.  The candidate will have an advanced knowledge of MDSAP, FDA, and ISO 13485 Quality Management Systems and have applied them to the workforce. Knowledgeable and use of problem-solving techniques is preferred.  The person should be a certified lead auditor. This person must have a working knowledge of Microsoft Office products, and experience with SAP is preferred.  The successful candidate will have:  

Possess effective written and verbal communication skills 

Strict attention to detail 

Driven by impact and is focused on results 

Acts as an entrepreneur and embodies a ownership culture 

Demonstrates ingenious big-picture thinking, manages ambiguity and makes decisions 

Has a winning attitude, fosters a winning spirit 

Inspires others, fights to win, takes and manages risks, accepts the occasional failure 

Empowered to take responsibility for results 

Audit- facing experience  

Who we are: We are a team of more than 73,000 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 annual base pay for this position is:

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 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.

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