Quality Engineer I/II - Manufacturing

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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

As a Quality Engineer I/II, you will support the company's Quality System by providing expertise in manufacturing and quality processes. You will offer guidance, training, and suggestions for improvement.

Key Responsibilities:

• Identifying opportunities for improvement within the Quality Management System (QMS) and implementing systems to enhance process efficiency.
• Monitor quality metrics and trends and lead the presentation of these insights during management reviews.
• Create and/or revise process control documentation, such as instructions, control plans, test methods, and graphical aids, as needed.
• Perform statistical analysis as applicable.
• Troubleshoot equipment, process and product issues, as needed.
• Participate in and assess customer complaint investigations, Non-Conformance Reports (NCRs), and supplier control documents.
• Provide quality engineering support and guidance on inspection methods and equipment, including measurement systems analysis.
• Contribute to new or updated product and process projects, including risk analysis, master validation plans, product verification and validation, equipment and process validations, and transferring designs to manufacturing as needed.

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. Additionally, this job requires analysis of data and continuous trending of metrics to evaluate the health of various processes.

CLINICAL WRITING

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

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.  

Within your first 30 days:  

• 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:  

• Exhibit a strong technical understanding of the manufacturing processes, 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 one year:  

• 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 processes and effectively troubleshoot challenges or obstacles that may affect project timelines.

Position Requirements

• Bachelor’s degree in an Engineering or Science, Technology, Engineering, and Mathematics (STEM) field or related education and experience.
• Must be self-motivated and capable of multitasking.
• Must possess excellent technical, written, and verbal communication skills, and demonstrate strong organizational abilities.
• Knowledgeable in product development, process optimization, risk analysis, continuous improvement, and verification/validation activities.
• Experienced in statistical process monitoring and data analysis software, with the ability to conduct product testing and apply technical documentation.
• Proficient in all Microsoft Office applications.

Preferred

• Up to five years of experience in the medical device or manufacturing industry, such as through internships or co-ops.
• 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.
• Knowledge in ISO 9001, ISO/IEC 17025, and other standards and regulations.
• American Society for Quality (ASQ) certification(s) such as Six Sigma, Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE).

Benefits

• Competitive compensation range: $70000 - $85000 / 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 - $85,000