Senior Quality Assurance Engineer

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 tasked with developing and implementing methods and procedures for process control, process improvement, testing and inspection to ensure that the products are 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 processes and change impact assessments

- Equipment and Process validations

- SOP and Risk Management documentation updates and reviews

- And more

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:

• Bachelor’s 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

Bachelor’s Degree in Engineering field REQUIRED

Great problem solving and critical thinking skills (4+)

Able to independently use engineering rationale make decisions (4+)

Knowledge/Experience with Validation (2+)

Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.