Job Description

Blatchford is an innovative, multi-award-winning, global, manufacturer of some of the worlds most advanced prosthetic technology, bespoke seating solutions and orthotic devices.

Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritize the wellbeing and long-term health of our users.

Through innovation, science, technology, and maintaining a clear focus on people, we make mobility possible.

We have an exciting opportunity for a Quality to join our global team and be based our US office in Miamisburg, Ohio.

The primary purpose if this role is to ensure the ongoing compliance and development of our Quality Management System, to ISO13485:2016, through continuous quality improvement, in accordance with regulatory requirements. As well as ensuring Health, Safety and wellbeing of staff and visitors, and providing and maintaining a safe and efficient work environment which meets legislative requirements. Reporting directly to the Head of QARA, you will lead the US quality team.

The role

Key duties:

• Ensuring compliance with regulatory requirements and ISO 13485:2016 in accordance with the groups quality management system.
• Leading and facilitating third party audits.
• Liaising with UK Head Office regarding quality and product related issues.
• Conducting internal audits and CAPA investigations, as required.
• Leading, coaching, motivating, and managing the team.
• Driving continuous improvement.
• Budgetary responsibility for the department.
• Central point of contact for health, safety, and environment advice.
• Assisting in the development of Safety Action Plans (SAP).
• Overseeing site safety training compliance

What are we looking for?

To be considered for this opportunity, you will have the following:

Essential skills

• Trained ISO 13485 Auditor
• Good working knowledge of Quality Management Systems.
• High level of experience of both ISO13485:2016, 21 CFR PART 820Quality System Regulation
• Understanding of EU MDR 2017/745
• Experience in a similar role in a Medical Device environment.
• Experience of health, safety, and environmental including OSHA
• Excellent team leader
• Demonstrated management experience
• Strong collaborator

What can we offer you?

As an employee of Blatchford US you will receive the following:

Benefits

• Highly competitive salary
• Excellent benefits
• Opportunity to be part of an award-winning organization with a culture that centers around our core values; courage, learning, integrity, collaboration, and innovation

The Company is an equal opportunity employer and does not discriminate against employees or applicants on the basis of race, color, religion, gender, national origin, disability, age, genetic information, veteran status or any other characteristic protected by federal, state or local law. The Company will make a reasonable accommodation to known physical or mental limitations of a qualified applicant or employee with a disability unless the accommodation would impose an undue hardship on our operation. Any employee who believes he or she may require such accommodation should contact Human Resources.

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