Quality Assurance Manager
4 weeks ago
ITW Medical is seeking a highly skilled Quality Assurance Manager to lead our quality assurance activities across multiple sites. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements, managing internal audits, and driving continuous improvement initiatives.
Key Responsibilities:- Compliance and Certifications: Maintain FDA QSR/ISO 13485-compliant Quality Management System, ensuring 100% alignment with Divisional Standards.
- Quality Management: Oversee management of validation activities, including new and change product/process validation, and participate in design reviews.
- Complaint and Corrective Action Management: Act as direct contact for customer quality-related issues, coordinate course of action, and ensure timely responses.
- Financial Management: Maintain product supply with minimum scrap and non-value-added activities, drive improvement using data-based information, and lead scheduled meetings.
- Department Management: Provide partnership with First Teams, manage talent acquisition, develop new hire onboarding plans, and guide the Quality team to manage daily production activities.
- Bachelor's Degree in Business Administration, Engineering, or related field required.
- 5-7 years of Quality Management experience, with multi-site experience and global cultural awareness, preferably in medical devices.
- Strong P&L leadership, financial acumen, and experience driving zero PPM in a lean manufacturing environment.
- Knowledge/experience with ISO 13485 and 21 CFR 820, or equivalent, quality system requirements.
- Ability to use MS Office Tools, such as Word, Excel, Project, and Access, and MiniTab or other statistics software.
- Excellent interpersonal, communication, and presentation skills, with the ability to build respect and trust within internal staff and external customers.
ITW Medical is an equal opportunity, equal employment, affirmative action employer. We strive to create a diverse and inclusive work environment where everyone is welcome to contribute their unique talents and ideas. We encourage applications from females, males, disabled/protected or other veterans, persons with disabilities, all races and ethnicities, sexual orientations, and gender identities.
ITW offers a competitive compensation and benefits package, including competitively priced medical and dental coverage, free life insurance, paid vacation and holidays, and immediate 401k matching. Additional retirement savings contribution is awarded at no cost after one year.
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