The qualified candidate will work as a member of the Manufacturing Quality Assurance group at the Mishawaka, IN site. As the new site quality engineering manager this individual will use their leadership skills to drive improvements in this 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, and drive supplier corrective actions to resolution.
This person will manage the site quality engineers to ensure site’s compliance to applicable external regulatory standards for the following:
o Provide quality engineering help w/ mfg. line problem resolution
o Drive process control & monitoring improvement
o Drive manufacturing process improvement activities to improve outgoing product quality, e.g. scrap reduction, SPC, improved test methods…etc.
o Support Process Validation activities
o Maintain mfg. compliance with regulatory requirements
o Provide operator training for new testing requirements
o Primary point to resolve QNs
· Test and Inspection
o “Own” all inspection and test requirements from incoming inspection to in-process testing to finished product testing.
§ Ensure statistical valid sampling plans at all phases of operations.
§ Ensure test & inspection methods are properly validated
§ Ensure that test & inspection methods address Critical to Quality requirements from the dFMEA and pFMEA requirements
§ Develop and implement improved test & inspection procedures, instruments, and methods.
o Own the Equipment Calibration process
§ Ensure equipment calibrations are performed
§ Ensure that equipment maintenance is performed
§ Review calibration records for accuracy
· Develop and maintain Process Control & Monitoring Plans & Programs
o Every key manufacturing process should have a robust Process Control & Monitoring Plan that is driven as an output from the process validation.
o Continual monitoring of process controls to drive improvement.
· Supplier Quality
o Perform supplier quality audits as assigned
· Audit Management
o Serve as Validation SME during audits
o Serve as test & inspection SME during audits
· Manufacturing Regulatory Compliance
· CAPA owners.
Education and Qualifications:
The successful candidate will possess a B.S. in science/engineering (preferred). The candidate will have at least 5-8 years of experience in Quality Assurance/Control Engineering Management, leadership role at a medical devices 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 must 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: managerial experience
· 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
· Empowers employees to take responsibility for results
· Supplier Audit experience
· SAP QM experience
· Familiar with Agile Practices
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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