Medical Quality Engineer Job Listing at Flex in Oostrum, LI (Job ID WD218373)

Description

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. 

A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

We are looking for a driven colleague who is passionate about quality, customer satisfaction, compliance and continuous improvement and have a significant part in bringing our organization to the next level for medical.

You will be supporting onboarding large new medical customer(s); being a bridge between Quality Assurance/Customer and Operations.

If you enjoy working in a challenging international environment and have work experience in a (medical) quality minded environment, please read on and explore if we are a match!

Here's a glimpse of what you'll do:

• Coordinates with other departments to ensure quality standards are maintained for medical customer(s);
• Identifies and escalates to Business Unit Management and/or Quality team if quality issues arise;
• Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Procedures in the organization
• Resolves quality related issues, report and (trend)analyses and advises on process improvements to ensure quality standards and customer requirements are maintained;
• Develop/gather content for training programs for internal users in subjects related to Customer requirements, Regulations or Quality Systems
• Responsible for documenting risk management for medical production lines and/or processes;
• Participates in establishing quality systems, compliance procedures, and quality objectives for medical customer(s);
• Take part in customer's, process and certification related audits. Ensures compliance with ISO 13485 standard, MDR (/FDA) and/or other applicable quality system regulations;
• Works closely with other members of the Quality team to set and achieve departmental goals.
• Setup and Supervise the Medical Quality Control Team.

What you'll need to have to be successful and happy in this role:

• Education and/or experience equivalent to a Bachelor's degree in Quality Engineering or a related field;
• Work experience in a (medical) quality minded environment, advice Managers on related topics and help create awareness;
• Experience with ISO 13485 (including software V&V is a plus), MDR (FDA is a plus)
• Capability to quickly absorb knowledge on related topics, methods and tools; Deal with resistance and able to question/understand the stakeholders and apply appropriate tactics;
• Fluent in English (written and oral);
• Pro-active, action oriented problem solving and analytical skills.

What do we offer:

• Flex offers a challenging job and opportunities for development in a dynamic and growing international company. We offer an attractive and competitive remuneration package based on your education and work experience. In consultation with your manager, you make agreements about your personal development, focused on your job and ambitions and will receive all necessary guidance and support.

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Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).