Product Development Quality Assurance Manager
1 mese fa
Job Description
Fresenius Medical Care seeks a Product Development Quality Assurance Manager to join our team. In this role, you will be responsible for ensuring the quality and reliability of our products, minimizing risk to users and patients, and maintaining regulatory and corporate SOP compliance.
Main Responsibilities
- Work closely with product development teams to ensure design control deliverables meet quality and regulatory requirements;
- Review and approve technical reviews, design reviews, and phase exit reviews;
- Create quality plans and deviation notices as needed;
- Provide training on design and development relevant quality requirements;
- Review and approve detailed impact assessments for level 2 design changes;
- Main contact for medical device PD-Accessories marked with the CE-mark;
- Ensure technical file completeness and up-to-date status;
- Submit declaration of conformity annually;
- Initiate, support, and release design changes (product safety change);
- Provide support during creation and maintenance of clinical evaluations;
- Manage post-market surveillance activities;
- Analyze PMS data collected and initiate required activities;
- Detect and report trends;
- Acts as a quality approver for design control related topics;
- Acts as a quality assignee for system-related topics;
- Define and track quality KPIs for continuous improvements;
- Drive continuous improvement in quality processes, tools, and methods;
- Prepare and conduct regular quality review meetings;
- Provide input to management reviews;
- Risk management throughout the complete product life cycle;
- Create risk assessments with support from risk management responsible;
- Assess potential product risks;
- Facilitate internal and external audits for Home;
- Act as an auditee for relevant chapters.
Requirements
- Bachelor's degree in a relevant field such as engineering, science, or quality assurance;
- 5+ years of experience in quality assurance, preferably in medical devices or a related industry;
- Strong understanding of design control, regulatory requirements, and quality systems;
- Excellent communication and interpersonal skills;
- Ability to work independently and collaboratively as part of a team;
- Experience with auditing and risk management;
- Knowledge of medical device regulations and standards;
- Proficiency in MS Office and other software applications.
Estimated Salary: $95,000 - $120,000 per year
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