Miamisburg, OH, 45342, USA
1 day ago
Quality Engineering Manager
A position at White Cap isn’t your ordinary job. You’ll work in an exciting and diverse environment, meet interesting people, and have a variety of career opportunities. The White Cap family is committed to Building Trust on Every Job. We do this by being deeply knowledgeable, fully capable, and always dependable, and our associates are the driving force behind this commitment. **Job Summary** Responsible for the quality oversight of design control and risk management activities. Work closely with product development teams, suppliers, and testing partners. Oversees the development, implementation, and continuous improvement of quality processes and procedures and ensures compliance with the relevant standards and regulatory requirements. **Major Tasks, Responsibilities and Key Accountabilities** **•** Lead Quality Engineering guidance and oversight for medical devices during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as life cycle management during design changes. **•** Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. through applying applicable company procedures and regulatory requirements. **•** Provide input to process manufacturing design and design transfer to ensure compliant, robust product realization. **•** Support compliance with filing and implementing changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions. **•** Support the timely handling of investigations, impact assessment, deviations and technical matters (i.e. design changes, verification and validation) with impact to design control and risk management. **•** Support internal and external audits and inspections as a Subject Matter Expert. **Nature and Scope** + Solutions require analysis and investigation. + Achieves planned results by decisions and actions based on professional methods, business principles, and practical experience. + Manages a group or team of professional individual contributors and/or indirectly supervises support staff. **Work Environment** + Typically located in a comfortable environment but with regular exposure to factors that may cause noticeable discomfort or a moderate risk of accident or illness, such as temperature extremes, moving machinery, loud noises, and fumes. + Frequent periods are spent standing or sitting in the same location with some opportunity to move about. Occasionally there may be a requirement to stoop or lift light material or equipment (typically less than 8 pounds). + Typically requires overnight travel 5% to 20% of the time. **Education and Experience** + Typically requires BS/BA in a related discipline. Generally 7+ years of experience in a related field. May require certification. Advanced degree may offset less experience in some disciplines. **Preferred Qualifications** If you’re looking to play a role in building America, consider one of our open opportunities. We can’t wait to meet you. **Functional Area** Field Operations **Recruiter** Lanaro, Gabriela **Req ID** WCJR-023140 White Cap is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer. White Cap considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender, gender identity, national origin, ancestry, citizenship, protected veteran or disability status or any factor prohibited by law.
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