Quality Systems Specialist I/Engineer I

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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 in a larger capacity than is possible in typical positions.

Position Description

Join Applied Medical as Quality Systems Specialist I/Engineer I and be at the forefront of revolutionizing medical device manufacturing. As a Quality Systems Specialist I/Engineer I, you will support the company’s Quality System by maintaining a thorough understanding of regulatory requirements in order to monitor and ensure conformance in all areas of the company.

Key Responsibilities:

• Standards Compliance and Documentation Management
• • Develop knowledge of standards, guidances and regulations and how they apply to the quality management system.
  • Manage document databases which maintain external documentation, links to relevant internal documentation, and change management records.
  • Identify, initiate, and actualize improvement projects for the managed database and other processes as needed.
  • Collaborate with other teams to act as a resource and subject matter expert as appropriate.
• Procedure Development and Change Management
• • Partner with various stakeholders on the creation and change management of procedures to support company growth and opportunities.
• Audit Support and Additional Responsibilities

• • Support external audits by efficiently retrieving and organizing requested documentation.

  • Perform additional tasks and responsibilities as assigned by leadership to support departmental and organizational goals.

Position Requirements

• Bachelor’s degree in Engineering, Physical, Biological Sciences, or other technical discipline, or equivalent years of relevant experience.
• Training in Quality Systems is preferred.
• Must have a strong internal desire to learn, self-motivated and capable of multitasking.
• Must possess excellent communication skills, and strong organizational abilities.
• Must be detail-oriented and quality minded.
• Proficient in all Microsoft Office applications.

Preferred

• Familiarity with ISO 13485, 14971, MDSAP, EU MDR, UK MDR, or other medical device standards and regulations.

If you are excited about making a significant impact, driving innovation, and contributing to a dynamic team, we encourage you to apply and embark on an exciting journey of engineering excellence at Applied Medical. Our unique business model empowers our team members to have a substantial impact, unlike conventional roles.

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.

Salary : $70,000 - $80,000