Quality Engineer I

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.

Position Description

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.

AREAS OF RESPONSIBILITY

As a Quality Engineer I, you will learn and develop skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team.

POSITION DESCRIPTION

• Conduct experiments to prove hypotheses

• Create and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, Gauge Repeatability and Reproducibility (R&R) and other relevant techniques

• Implement statistical techniques to determine sample sizes and levels of confidence

• Implement statistical process controls to monitor validated processes

• Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports

• Perform root cause investigations for design and manufacturing

• Document Non-Conformance Investigations (NCIR)

• Document and implement Corrective and Preventative Actions (CAPA)

• Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)

• Collaborate with design and manufacturing teams to assess device risk profile and failure modes in Design Failure Modes and Effects Analysis (dFMEA) and Process Failure Modes and Effects Analysis (pFMEA)

DATA ANALYSIS

The job requires conducting thorough investigations and analyses to identify the underlying causes of problems or failures and develop effective solutions to prevent their recurrence.

CLINICAL WRITING

This role will ensure the accuracy, clarity, and compliance of our documentation, reports, and technical materials related to our products and processes.

COMPREHENSIVE KNOWLEDGE

The job necessitates understanding of IQ, OQ, and PQ processes to ensure compliance with regulatory standards and validate the proper installation, performance, and operation of equipment and systems.

PERFORMANCE OBJECTIVES

Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

During your first 30 days, you will:

• Learn about Applied's mission and vision and take part in a variety of Applied Learning foundational courses

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

• Immerse yourself in team meetings and discussions

Within 60 days, you will:

• Exhibit a strong technical understanding of the product lines and projects

• Support team meetings and agendas

• Take on one or more projects that require low to moderate guidance

Within 90 days to 1 year, you will:

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

• Lead moderate to complex projects with minimal guidance or direction

• Demonstrate a strong understanding of Applied's Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines

• Handle a variety of projects on your own

Position Requirements

This position requires the following skills and attributes:

• Bachelor's degree in an Engineering or Science, Technology, Engineering, and Mathematics (STEM) field or related education and experience

• Effective oral and written communication skills

• Excellent technical writing skills

• Ability to work effectively in cross-functional teams

• Ability to read, analyze and interpret complex documents

• Working knowledge of Microsoft Office, including Word, Excel, and Outlook

Preferred

The following skills and attributes are preferred:

• Experience in the medical device industry, such as through internships or co-ops

• Engineering capstone projects related to medical or surgical devices

• Experience in process verification and validation procedures

• Experience with project management tools, including Microsoft Project

• Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab

• Understanding of manufacturing, quality, and risk management standards

Benefits

The base compensation range for this role is $68000 - $78000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company's sole discretion, consistent with the law.

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans].

Our total reward package also includes the following:

• Training and mentorship with ongoing learning and development courses

• On-campus wellness activities

• Comprehensive medical and dental and vision coverage

• Education reimbursement program

• 401(k) program with discretionary employer match

• Generous vacation accrual and paid holiday schedule

All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.

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.