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
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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