PM - Quality Engineer I
7 days ago
Develops, modifies, applies, and maintains quality standards and evaluation methods for products and
processes. Provides moderately complex statistical information for quality improvement by determining
and applying testing methods and criteria. Coordinates and guides technical evaluations, analysis, and
related data acquisition processes to ensure division quality objectives are achieved.
Roles and Responsibilities:
ESSENTIAL FUNCTIONS:
Assesses quality performance (or cost-of-quality) using statistical and analytical methods. Devises and
implements methods and procedures for inspecting, testing, and evaluating the precision, reliability, and
accuracy of products, processes, and production equipment.
Develops and establishes quality systems and procedures, inspection plans, quality performance trends,
statistical plans cost estimates, and technical quality plans for proposals. Ensures that project and/or
process control documentation is compliant with requirements and/or contract.
Assesses the cost of, and determines the responsibility for, products or materials that do not meet
required standards and specifications by performing statistical analyses. May establish statistical
confidence by identifying sample size and acceptable error and determining levels of confidence.
Assures the timely processing of nonconforming materials and assists in the disposition process by
participating in failure analysis and corrective action investigations as a member of the Material Review
Board.
Coordinates with customers and suppliers relating to quality performance, trends and corrective action.
Verifies compliance and effectiveness of the quality system by performing supplier audits and surveys.
May initiate programs to improve supplier performance.
May design or specify inspection and testing mechanisms and equipment and conduct quality assurance
tests. Develops experiments by applying factorial or other techniques as appropriate for product or
process.
Participates on product development teams to review engineering releases and changes, manufacturing
methods, planning, and process specifications as it relates to product quality.
Develops sampling plans by applying attribute, variable, and sequential sampling methods. Devises
sampling procedures and designs and develops forms and instructions for recording, evaluating, and
reporting quality data.
Develops statistical process controls by applying and maintaining applicable control charts. Analyzes
data and trends by completing hypothesis, normal distribution, and process capability analysis tests.
Refines and enhances products and processes by applying continuous improvement and key lean
manufacturing/production principles and techniques to areas of production.
Prepares reports by collecting, analyzing, and summarizing data and making recommendations.
Compiles and writes training material and conducts training sessions on quality control activities.
Maintains professional and technical knowledge by attending educational workshops, reviewing
publications, establishing industry networks, benchmarking state-of-the-art practices, maintaining
American Society for Quality certification, and/or participating in professional associations.
Complies with federal, state, and local legal requirements by studying existing and new legislation,
enforcing adherence to requirements, and advising management on needed actions. Provides
information and develops corrective action measures by interfacing with customers and regulatory
agencies and assisting in internal and external audits.
Shares specialized knowledge with others. Represents Company on specific projects. Mentors new
employees. Contributes to team effort by accomplishing related results as needed. Work assignments
may include cross-functional or project team responsibilities (e.g. continuous improvement).
Qualifications and Education Requirements:
Bachelor's degree (BS) in Engineering or a related technical discipline. Demonstrated ability to perform
the essential functions of the job typically acquired through two or more years of related experience.
American Society for Quality certification desired.
Practical knowledge of state-of-the-art inspection and quality engineering/assurance techniques,
procedures, instruments, equipment, theories, principles and concepts and general business operations.
Knowledge of aerospace industry or similar industry products and legal and regulatory requirements
related to field. Ability to effectively apply continuous improvement principles and techniques to quality
and manufacturing functions. Ability to use standard business software applications and/or specialized
data analysis tools. Ability to work on a variety of problems of moderate scope and complexity where
analysis of the situation or data requires thorough identification of factors and analysis of impact; work
within general work objectives regarding projects and team goals. Ability to read, analyze, and interpret
scientific and technical journals, and financial reports. Ability to effectively communicate and present
information to team members, team leaders, and top management; respond to significant inquiries or
complaints from customers, regulatory agencies, or members of the business community. Ability to
interpret a broad variety of technical instructions in mathematical or diagram form that include several
abstract and concrete variables. Ability to define problems, collect data, establish facts, and draw valid
conclusions. Ability to use full discretion in selecting procedures and techniques to apply to work and
determine priority and order of assignments. Ability to effectively demonstrate team member
competencies and participate in goal-setting, performance feedback, and self-development activities.
Must have a valid driver's license and current state required minimum vehicle insurance coverage to drive onto Client and Company property.
Preferred Skills:
Pay Range:
The pay range for this position is $45.67-$48.07 per hour; however, the pay offered may vary depending on job-related knowledge, skills, and experience. This pay information is being provided pursuant to applicable law and is based in part on market location.
Benefits:
The benefits available with this position include:
- Ongoing Training (RSO, Systems, Software Programs, OSHA Safety, JJ Keller, etc.)
- Continuous Employment Development and Learning
- Ongoing Advocacy, internal assets with HSE, Legal and HR teams and experts to aid in Employee Career Path and Advancement
- 401K
- Healthcare & Healthcare Group Medical Coverage
- Dental Insurance Coverage
- Vision Insurance Coverage
- Basic Life Insurance & AD&D
- Long Term Disability
- Voluntary Short-Term Disability
- Access to Health Joy
- GAP Medical Coverage
- Direct Deposit
- Health Savings and Flexible Spending Accounts
Cenergy is a dynamic, diverse, woman-owned company that has provided stellar support to our clients globally for over 25 years We hire extraordinary people, and each of our team members are encouraged to embody our core values to drive innovation and own it with integrity and trust while adding to our positive and forward-thinking atmosphere.
-
Quality Engineer I
3 weeks ago
Irvine, United States The Judge Group Full timePosition Title: Quality Engineer I Duration: Contract Work Location: Irvine, CA Job Duties: Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance. Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor...
-
Quality Engineer
2 weeks ago
Irvine, United States Bio-Rad Laboratories Full timeAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The...
-
Quality Engineer
3 weeks ago
Irvine, United States Bio-Rad Laboratories Full timeAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The...
-
Quality Management Systems Engineer
7 days ago
Irvine, United States SysMind Tech Full timeRole name: Engineer Role Description: Quality Management Systems, FDA, Presentation, Strong communication skills, ISO 13485, Medical Device, Regulatory Standards, Quality Compliance, CAPA / NC Competencies: EIS : Medical Device & Regulations Experience (Years): 6-8 Essential Skills: A minimum of Technical/Engineering Degree with 8+ years of related...
-
Quality Engineer II
7 days ago
Irvine, United States AbD Serotec Full timeAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The...
-
Quality Engineer II
7 days ago
Irvine, United States Bio-Rad Laboratories Full timeOverview As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate...
-
Quality Engineer II
4 days ago
Irvine, United States Bio-Rad Laboratories Full timeJob DescriptionAs part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate...
-
Quality Engineer
3 months ago
Irvine, United States Entegee Full timeJob DescriptionJob DescriptionSummary: Seeking a Quality Engineer to lead the development and optimization of manufacturing processes, execute complex tests, and address quality and compliance issues within the medical device industry.Requirements:Bachelor's degree in engineering.5-7 years of experience in a related field.Proficiency with engineering...
-
Senior Quality Engineer, Commercial Quality
7 days ago
Irvine, United States Edwards Lifesciences Full timeAortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart...
-
Quality Assurance Engineering Lead
4 days ago
Irvine, California, United States Nihon Kohden Full timeSenior Quality EngineerWe are seeking an experienced Senior Quality Engineer to lead our quality assurance efforts. The ideal candidate will have a strong background in electrical engineering and quality management systems.
-
Quality Engineer II
2 days ago
Irvine, United States Planet Pharma Full timeQuality Engineer II Location: Irvine, CA Contract Duration: 6 months Target Pay Rate: $42/hr. with flexibilityAbout the TeamOur group focuses on New Product Development (NPD) quality and design assurance for medical devices, particularly in the area of transcatheter heart valve replacement (TAVR). This is a transformative area of healthcare, offering...
-
THV Quality Engineer
1 day ago
Irvine, California, United States Entegee Full timeJob DescriptionEntegee is seeking a THV Quality Engineer to lead quality assurance activities for our medical device products.Key ResponsibilitiesInvestigate product quality and compliance issues in the field, analyze results to identify root causes.Perform hands-on device testing using various test equipment to determine root causes.Assess events against...
-
Senior Quality Engineer
4 months ago
Irvine, United States ShiftCode Analytics Full timeTitle: Senior Quality Engineer (Design) Location: Irvine, CA On-site Duration: 6 months+ Visa: Any Visas(except h1b and CPT) Interview: Phone/Zoom Key Role Responsibilities: • Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to...
-
THV Quality Engineer
3 months ago
Irvine, United States Entegee Full timeJob DescriptionJob DescriptionSummary: Seeking a THV Quality Engineer to investigate product quality issues, perform device testing, and manage complaint investigations in the medical device industry.Requirements:Bachelor's degree in engineering with 0 - 2 years of related work experience.Experience with medical device complaint investigations, including...
-
Quality Assurance Engineer
5 days ago
Irvine, United States Western Mutual Insurance Company Full timeThe Western Mutual Insurance Group has been providing excellent customer service to homeowners throughout the Southwestern United States for over 80 years. We are rated A (Excellent) by A.M. Best Company and have been named among the Top 50 Property Casualty Insurers in the country by Ward's.Our constant endeavor in employee relations is to maintain a...
-
Quality Engineering Manager
7 days ago
Irvine, United States Q CELLS USA Corp. Full timeDescription POSITION DESCRIPTION: EnFin is seeking a highly skilled and motivated Quality Engineering Manager to lead our software quality assurance and testing efforts. The successful candidate will be responsible for defining testing strategies, ensuring high-quality software releases, and driving process improvements. The role requires strong leadership,...
-
Software Engineer
1 week ago
Irvine, California, United States Insight Global Full timeWe are looking for a skilled Software Engineer to join our team at {company}. The successful candidate will be responsible for designing, developing, and maintaining our software applications.Main Responsibilities:Design and implement software applications using programming languages such as Java and PythonCollaborate with cross-functional teams to identify...
-
IT Operations Engineer I
6 hours ago
Irvine, United States Hensel Phelps Full timeDescription Any Employment Offers are Contingent Upon Successful Completion of the Following: Verification of Work Authorization and Employment Eligibility Substance Abuse Screening Physical Exam (if applicable) Background Checks for Badging/Security Clearances (if applicable) About Hensel Phelps: Founded in 1937, Hensel Phelps specializes in...
-
Senior Quality Assurance Engineer
3 days ago
Irvine, California, United States Entegee Full timeJob OverviewWe are seeking a skilled Senior Quality Assurance Engineer to join our team at Entegee, a leader in custom automation projects and robotic solutions. In this role, you will play a crucial part in ensuring the quality and compliance of our medical devices.Salary RangeThe estimated annual salary for this position is $71,600 - $83,200, based on an...
-
Senior Software Engineer
4 days ago
Irvine, California, United States Exsilio Solutions Full timeAbout the RoleAt Exsilio Solutions, we are seeking a skilled Software Engineer to join our team. As a key contributor to our web application development practice, you will be responsible for designing, developing, and maintaining scalable applications that meet the needs of our clients. Key ResponsibilitiesAssess customer environments and requirements to...