Quality Assurance Specialist
3 weeks ago
Quality Engineer
We're seeking a Quality Engineer to play a vital role in maintaining, monitoring, and improving our Quality Management System (QMS) at the Sudbury Site. As a key member of the Manufacturing Operations Team, you'll be responsible for developing a culture of Quality through education, mentoring, and example.
Your Key Responsibilities:
- You'll provide Quality support to the Manufacturing Operations Team, ensuring timely and accurate completion of CAPA & Issue Resolution.
- You'll administer and support the deviation process to guarantee timely and accurate completion.
- You'll prepare for supplier, customer, regulatory, and notified body audits as required.
- You'll prepare, review, and approve or reject quality-related documentation.
- You'll provide support for training in key aspects of the Quality Management System.
- You'll generate quality-related metrics, reports, and KPIs and lead improvement projects and quality initiatives.
- You'll participate in SQDIP meetings, provide accurate and timely reports, and take responsibility for the achievement of target KPIs for the role.
Your Expertise:
- 5+ years' experience in an engineering/manufacturing environment
- In-depth knowledge of Quality Management Systems, ISO 13485/9001, 21 CFR 820
- IT literate with strong knowledge of Microsoft Office packages
- Good Documentation Practices & Good Manufacturing Practices
- Ability to manage time effectively and possess a desire to succeed
- Effective team member and able to communicate across functions
Our Benefits:
- 26 days' holiday with the option to buy or sell an additional 5
- Up to 10% employer pension contribution
- Share and bonus scheme
- Access to our flexible benefits from private medical insurance to dental cover
- Corporate Social Responsibility opportunities, including 2 paid volunteering days per year and support from our 24/7 employee assistance programme
About Us:
We're a team of over 71,000 highly dedicated Healthineers in over 70 countries. As a leader in medical technology, we push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they're facing.
We're from different backgrounds, cultures, religions, political and/or sexual orientations, and work together to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
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