Quality Assurance Manager
4 weeks ago
Job Title: Quality Assurance Manager
Job Summary:
FUJIFILM Corporation is seeking a Quality Assurance Manager to oversee the communication of quality information to external and internal customers. This role is responsible for ensuring that quality information is accurately communicated and that customer needs are met.
Key Responsibilities:
- Oversee the QA Support group and Audit Management group, including functions, planning, systems, and personnel.
- Coach, train, and help personnel within the group to grow and advance in their knowledge and job function.
- Ensure customer communication is completed fully and in a timely manner.
- Ensure audits are performed as planned, responded to, and their actions are completed per the agreed-upon timeframes.
- Report and track department activities to ensure KPIs are met.
- Help customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow-up, etc.).
- Act as a customer liaison for internal inquiries and provide a voice of the customer.
- Manage customer surveys, issues, and questionnaires completion.
- Manage supplier questionnaires and qualification.
- Manage audit programs.
- Manage change notifications and supplier management (qualification, re-evaluation, material qualification, performance monitoring).
- Assist with coordination of quality activities for related FISI production sites.
Requirements:
- BS/BA in Biology, Microbiology, or Chemistry preferred.
- 3-5 years of QA experience in a medical device or biopharmaceutical environment.
- Minimum of 3 years management or supervisory experience required.
- Must be familiar with FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada, and MDR requirements.
- Excellent computer skills, including MS Word, Excel, PowerPoint.
- Ability to speak, read, and write proficiently in English.
- Good oral and written communication skills.
Salary and Benefits:
$99,100-$129,100 depending on experience.
Medical, dental, vision.
Life insurance.
401(k).
Paid time off.
FUJIFILM Corporation is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
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