Senior Quality Engineer

Job Description

Job Description

Job Description:
As a Senior Quality Engineer you will provide quality engineering support in quality assurance, control and preventative activities within operations and other business functions.
You will be specifically tasked with supporting EU-MDR initiatives for a portfolio of products. To do so you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are compliant to applicable regulations, free of flaws and function as designed.

You will be Expected to Support:
First Article Inspection (FAI) strategy development, execution, and approvals.
Production Part Approval Process (PPAP)
Change control and change impact assessments
Support SOP and Risk Documentation updates and reviews
Equipment and Process validations
And more
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience.
You will advocate and lead the execution of initiatives & projects to enhance quality performance within the business and ensure compliance to regulations and standards.

Expected Qualifications:
Bachelors Degree Biomedical Engineering, Mechanical Engineering or related field
4 + years of experience in industry required
Experience supporting EU-MDR programs
Knowledge of Change Management and Quality Management Systems (QMS) principles.
Firm understanding of Med Device concepts highly desirable.
Familiarity with ISO 13485 and EU Regulations, GDP, GMP concept highly desirable.
Excellent communication skills and attention to detail.
Good understanding of engineering and quality concepts / theories.
High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
Self-starter with efficient work style and ability to handle multiple tasks in a fast-paced environment.
Be willing to work as part of a multi-site team.
Have knowledge of Risk Based and statistical concepts is desirable.
Problem solving and analytical skills.
Be able to build strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.
Ability to be the voice of Quality when dealing cross functionally.
Excellent English (both oral and written).
Up to 10% travel may be required

Bachelors Degree in Engineering field Required
Great problem solving and critical thinking skills (4+)
Able to independently use engineering rationale make decisions (4+)

Knowledge/Experience EU-MDR Programs/Initiatives (2+)