Quality Assurance Manager

Job Description

The 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

Qualifications

Additional Information

All your information will be kept confidential according to EEO guidelines.

Disclosure requirements pertaining to the collection of your personal data:

Responsible for processing the information provided in your application is the company specified in the job advertisement, with its registered office as indicated. The company processes your data for the purpose of establishing an employment relationship on the basis of Art. 6 (1) b GDPR / Section 26 (1) sentence 1 BDSG.

The retention period for your data is determined by the statutory time limits applicable in the respective country, beginning upon completion of the recruitment process. You can find these here.

You can contact the company’s Data Protection Officer at the above-mentioned postal address. 

Further information on data protection and your rights can be found here.

We strive to be an equitable and inclusive workplace for our employees and value their diverse perspectives, which contribute to the diversity of our company. Therefore, we welcome applications from people who enrich our company with their identity, background and personal experience. We want to keep the application process as simple as possible for you: focus on a meaningful resume; we do not require an elaborate cover letter. Please know that we can only accept your application through our online application portal.

Learn more about our commitment to Equal Opportunity and Accommodation Information here.

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