Job DescriptionThe position of the QA Manager Healthcare includes all activities related to Quality Assurance of
pharmaceutical products and medical devices to ensure a proper implementation of the quality
policy, the quality assurance system, the compliance with GMP/GDP rules and all GxP
requirements in accordance with e.g. EN ISO 9001, EN ISO 13845 and other country specific
requirements. This role is also responsible for ensuring that all requirements for Quality Assurance are
understood and adhered to by the respective departments.
YOUR TASKS- Continuous improvement and compliance of the local quality management system (ISO 9001, ISO 13485 and other country specific requirements (e.g. GDP, GMP, FDA, etc.)
- Flexible adaptation of the Quality Management System to all requirements (e.g. requirements of authorities, customer requirements)
- Oversight of all quality technical related processes, e.g. maintenance, calibration, pest control
- Supporting the strategic implementation of the Quality policy and Global Quality System
- Reporting of quality KPIs and enforcement of the specified quality in cooperation with all departments involved, including Complaints / Deviations / CAPA / Change Management
- Responsible for the execution of training, according to the respective requirements• Decision on the further use of products (blocking, release)
- Guarantee of the written separation of responsibility with the customer and suppliers regarding all activities
- Close collaboration with other departments, e.g. sales and account management, as well as the global quality team
- Participation in project and process alignments, preparation and performance of management reviews
- Completes assigned MasterControl Action Items within required timelines to ensure timely resolution and compliance with quality system expectations
YOUR PROFILE- Bachelor's degree in a scientific, technical, or quality-related field; or equivalent work experience
- 5+ years of experience in a quality role in a regulated environment (medical device, pharma, biotech, or logistics)
- Working knowledge of ISO 9001, ISO 13485, and FDA 21 CFR Part 820 requirements
- Proficient in document control systems and training program coordination
- Excellent attention to detail and organizational skills
- Strong verbal and written communication abilities
- Proficiency with Microsoft Office.
- ISO Lead Auditor Certification preferred
- Experience with MasterControl or similar eQMS platforms preferred
WE OFFER- Medical, Dental, Vision, Life Insurance, and Disability Pay
- 401(k) with company matching up to 6%
- Paid Time Off, including paid holidays
- Flexible Spending Accounts
- Voluntary benefits such as legal and financial assistance, pet insurance, and more
- Employee Assistance Program
- Ongoing employee development opportunities including tuition reimbursement, scholarships, and training
- Commuter benefits
- Employee engagement activities
QualificationsAdditional Information 
