Head of Quality Management Details

Head of Quality Management

ZEISS Group - Dublin, CA

Employment Type : Full-Time

Head of Quality ManagementDublin, CA

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

We are looking for people who are keen to try something new:The Sales and Service Company Head of Quality Management is responsible for the planning, supervision and leadership of the Quality team and overall Quality Management Systems including but not limited to Auditing & Compliance, CAPA, Complaint Handling, Field Corrective Actions, and Document Services.

Duties and Responsibilities include:

• Manage Quality Management Systems, Management Reviews, Quality Assurance of processes, Document Control, Auditing and Compliance, CAPA, Complaint Handling, and Field Corrective Actions
• Ensure compliance with applicable state, federal, and international regulations, and standards
• Ensure company is aware and comply with Quality obligations on contractual agreements (Quality Assurance Agreements) with Zeiss affiliates
• Guide project teams to ensure that quality system requirements for company are met.
• Extensive experience in the design and management of complaint handling processes and integration into a complaint handling system
• Experience in interacting with customers and their vigilance organizations to complete and close complaint investigations manage business related complaint issues
• Experience in communicating with internal and global business affiliates to complete complaint investigations
• Strong leadership skills, self-directed and the ability to make compliance decisions independently, and able to work effectively in a team environment
• Experience with statistics and the application of statistics in data analysis and trending
• Contribute and collaborate with Carl Zeiss Meditec Quality on matters of Quality Management Systems, particularly related to Sales and Service Company.
• Strong communication skills.

You are:

• Education: B.S. Engineering, life sciences, or business required.
• Minimum experience: Five (5) to seven (7) years supervisory /people management (or equivalent) experience required.
• Minimum experience: Five (5) years in medical device industry or quality management experience required; including quality systems and product quality assurance.

KNOWLEDGE, SKILLS & ABILITES:

• Excellent knowledge of 21CFR820 regulation, and ISO13485 or ISO 9001 standards
• Excellent knowledge of Complaint Handling, Medical Device Reporting, and Field Corrective Action processes
• Intermediate knowledge/skills with word-processing, spreadsheet and document management software required
• Excellent communications, people management, and time management skills
• Strong organizational skills
• Strong collaboration skills locally and in an international environment

In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.