- 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
- 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
- ASQ-CQA (American Society for Quality - Certified Quality Auditor) or other auditor certification
- Competitive compensation range: $ $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.
-
Software Quality Engineer
2 weeks ago
SMS Staffing Inc. Lake Forest, United StatesJob Description · Job DescriptionSMS Staffing Inc is Hiring Immediately for a skilled Software Quality Engineer Job Title: Software Quality EngineerJob Location: Lake Forest, IL, U.S.A OR one of the CA locationsJob Type: Contract (possible extension or convert to hire)Pay: Starts ...
-
Quality Specialist/ Engineer
2 weeks ago
843045256 Lake Forest, United StatesJob Description · Job DescriptionBenefits:Volunteering Paid Days · Simple IRA · Financial Advisor · Dental insurance · Health insurance · Paid time off · If you like to innovate, are self-reliant with strategic mind thinking, and interested in giving your full potential to this s ...
-
Quality Engineer
1 week ago
Motion Recruitment Irvine, United StatesWe are looking for a Quality Engineer to ensure regulatory compliance and optimize product development and manufacturing. It requires a bachelor's degree in engineering, 5-7 years of experience, and skills in CAD, communication, and problem-solving. · Job Responsibilities: · Appl ...
-
Quality Engineer
2 weeks ago
TalentBurst, an Inc 5000 company Irvine, United StatesPosition: Sr. Quality Engineer, Req#: 6948-1 · Location: Irvine, CA (100% onsite) · Duration: 9+ Months Contract · Job Description: · The main function of a quality engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing productio ...
-
Quality Engineer
2 weeks ago
Compunnel Inc. Irvine, United StatesJob Description: The main function of a Senior Post Market Quality Engineer is to perform engineering evaluation for customer complaints and support Post Market Surveillance activities. · Key Responsibilities: · • Manage Customer Complaints Engineering Evaluations during the cour ...
-
Senior Quality Engineer I
1 week ago
STAAR Surgical Lake Forest, United StatesMAIN JOB RESPONSIBILITIES / COMPETENCIES · 1. Coordinate quality engineering activities to achieve business objectives. · 2. Provide guidance and leadership on development /review of validation policies, master plans and schedules, and protocols and quality engineering issues. ...
-
Quality Engineer
1 week ago
Intellectt Inc Irvine, United StatesRole: Sr. Quality Engineer · Location: Irvine, CA – 92614 · Job Type: Contract · Summary: · This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Global Supply Chain. · This cross functional partner will: · Interact with various ...
-
Quality Engineer
2 weeks ago
Cypress HCM Irvine, United StatesQuality Engineer II · How You'll Make An Impact: · Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including: · Analysis of post market data and reviewing completed reports with business partners. · Maintaining and supporting databases and s ...
-
Quality Engineer
3 weeks ago
GForce Life Sciences Temecula, United StatesWHAT YOU'LL DO: · Identify internal requirements and external laws, regulations, guidance, and standards (LRGS) relevant to the division's quality systems. · Ensure that internal activities and external partnerships adhere to applicable regulations and quality standards, includ ...
-
Quality Engineer
4 days ago
INTELLECTT INC Irvine, United StatesRole: Sr. Quality Engineer · Location: Irvine, CA – 92614 · Job Type: Contract · Summary: · This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Global Supply Chain. · This cross functional partner will: · Interact with va ...
-
Quality Engineer
2 weeks ago
TalentBurst Irvine, United StatesShort-term (3 months only with no possibility of extension/conversion) contract jobs. · Position: Quality Engineer I (Complaint Investigations/ Post Market Surveillance), Req#: 6086-1 · Location: Irvine, CA (100% onsite) · Duration: 3 Months Contract · Job Description: · Thi ...
-
Quality Engineer
3 weeks ago
Motion Recruitment Irvine, United StatesTitle: Engineer-1 (Quality) · Location: Irvine, CA · Duration: Contract · About the Client: · Join a distinguished member of the Fortune 100 community, specializing in cutting-edge medical devices tailored for critical care, structural heart interventions, and surgical monitorin ...
-
Quality Engineering
3 weeks ago
INTELLECTT INC Irvine, United StatesRole : Quality Engineering / Compliance Specialist · Location : Irvine, CA · Duration : 9 Months · Skills Looking For · Working on complaint evaluation for a medical device company · Responsibilities include intake, investigation, and summary writing for complaints · Basic co ...
-
Quality Engineer
2 days ago
A2T TECHNOLOGY INC. Irvine, United StatesJob Description · Job DescriptionEnsure that internal activities and external partnerships adhere to applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485. · Apply quality and regulatory standards to medical equipment and process qualification. · ...
-
Quality Specialist Engineer
1 week ago
843045256 Lake Forest, United StatesBenefits: · Volunteering Paid Days · Simple IRA · Financial Advisor · Dental insurance · Health insurance · Paid time off · If you like to innovate, are self-reliant with strategic mind thinking, and interested in giving your full potential to this small business, this position m ...
-
Senior Quality Engineer
2 weeks ago
Q2 India Mission, United StatesAs passionate about our people as we are about our mission. · What We're All About · : · Q2 is proud of delivering our mobile banking platform and technology solutions, globally, to more than 22 million end users across our 1,300 financial institutions and fintech clients. At Q ...
-
Engineer Staff, Quality
19 hours ago
MicroVention Aliso Viejo, United StatesJob Description · Production Support Focus · Lead quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improve ...
-
Quality Engineer
1 day ago
Collabera Temecula, United StatesSummary: · As an intermediate Quality engineer, this candidate will be supporting the quality engineering activities in Reliability engineering lab, including equipment qualification activities, · Supporting equipment calibration and maintenance, · Coordinating with various teams ...
-
Quality Engineer
6 days ago
A&M Biomedical Inc Laguna Woods, United StatesThe Quality Engineer is responsible for ensuring the overall quality of the production processes A&M Biomedical provides its customers. The QE is tasked with creating documentation, devising quality tests and defining the criteria a test result should meet. The QE reviews drawing ...
-
Quality Engineer
2 weeks ago
Pathway Group Huntington Beach, United StatesJob Description · Job DescriptionQUALITY ENGINEER · JOB SUMMARY · The Quality Engineer is responsible for monitoring the performance of customer and internal KPI. This role champions improvements using analysis and implements corrections and improvements using quality tools such ...
Quality Engineer - Rancho Santa Margarita, United States - Applied Medical
Description
_________________________________________________________________________________:
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 Auditors 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.
This position requires the following skills and attributes:
The following skills and attributes are preferred:
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: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.