Quality Engineer - Internal Auditor

As a new generation medical device company, Applied Medical is equally committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies that enhance clinical care, while offering boundless opportunities for professional growth.

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

Position Description

As a Quality Engineer

• Internal Auditor, you will work within the Quality Team and with cross-functional teams. The Internal Auditor's primary responsibilities are to audit Standard Operating Procedures (SOPs) and Industry Standards to ensure compliance.

Audit and Quality Control Processes

You will be responsible for prioritizing tasks and working within tight deadlines. You will also develop audit schedules, plans, and reports, prepare, and lead audits and participate in team meetings.

Communication

You will have the ability to successfully convey and exchange information and ideas with management and others. Communication is imperative. You will need to effectively communicate with cross-functional teams, ensuring that Quality Auditing requirements are met and comply with standards.

Problem Solving

You will be responsible for identifying and resolving problems that arise, including taking action to solve the problem by generating ideas for the solution, finding out the reasons behind the problem, and implementing the solution.

Performance Objectives

Within your first six months, you will be responsible for learning about our company, preparing, and participating in audits.

• During your first 30 Days:

• Learn about our Applied Medical mission and vision through participating in a variety of Applied Medical Learning foundational courses

• Discuss your goals and expectations with your team leaders and read and review all relevant training

• Immerse yourself in team meetings and discussions

• Within 60 Days:

• Exhibit a strong technical understanding of the quality auditing process

• Support team meetings and agendas

• Participate in one or more audits

• Within 90 Days to One Year:

• Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables

• Lead audits with minimal guidance or direction

• Demonstrate a strong understanding of Applied Medical Quality Management Systems (QMS) and effectively troubleshoot challenges or obstacles that may affect timelines

Position Requirements

This position requires the following skills and attributes:

• Bachelor's degree or equivalent in Quality Assurance or regulated manufacturing

• Minimum of two years auditing proficiency in QMS

• Prior training in Quality Systems and familiarity with relevant regulations and standards

• Ability to interpret regulations and assess their impact on quality

• Proficiency in statistical techniques for analyzing QMS

• Strong independent work ethic and ability to collaborate effectively within a team

• Attention to detail and effective communication skills

• Strategic thinking and multitasking abilities

• Customer-focused with a flexible approach to work

Preferred

The following skills and attributes are preferred:

• ASQ-CQA (American Society for Quality

• Certified Quality Auditor) or other auditor certification

Inside This Business Group

Quality Engineer

• Internal Audit Team audits Quality Management Systems for compliance, collaborating with cross-departmental team members and Subject Matter Experts. They assess effectiveness, identify improvements, and provide recommendations for enhancing quality management practices.

Benefits

• Competitive compensation range: $68000 - $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.