Applied Medical

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Applied Medical is a new-generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.

Position Description

Are you a Quality Engineer/Specialist I ready to drive impactful change in a fast-paced environment? Join Applied Medical and play a key role in ensuring the highest standards of quality in our medical device manufacturing. As a Quality Engineer/Specialist I in a cutting-edge medical device company, you will play a critical role in maintaining and improving our Quality Management System (QMS). Your expertise will ensure global compliance of our QMS to applicable standards and regulations (e.g., ISO 13485, EU MDR, etc.). Join us in this pivotal position to safeguard product integrity and support innovative healthcare solutions.

Key Responsibilities:

• Collaborate on Regulatory and Quality Project Management: Partner with various stakeholders on the creation and change management of procedures to support company growth and opportunities.
• Communication: Guide team members on process interactions within the organization by providing proactive support and information.
• Problem Solving: Plan, organize, and facilitate multiple projects in compliance with standards and regulations to address concerns and future needs.

Position Requirements

• Bachelor's in Engineering, Biological Sciences or a related scientific field is preferred, equivalent years of relevant experience.
• Experience working within an ISO 13485 certified QMS.
• Analytical, meticulous, and detail-oriented.
• Assertive and not afraid to ask questions.
• Positive attitude and customer service oriented.
• Able to multi-task, organize, and prioritize.
• Highly motivated, self-starter, able to work independently and as part of a team.

Preferred

• Strong understanding of industry regulations, standards, or guidance documents.
• Experience with project management tools, including Microsoft Project.

Benefits

• Competitive compensation range: $70000 - $80000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.