Quality Engineer II
Full Time + Benefits (Medical, Dental, Vision, 401k with Company Match, PTO)
Job Type: Onsite
Shift: 1st 8:00 AM – 4:30 PM, M-F
Hours: 40 Hours per week/ 80 hours every 2 weeks
Salary Range: $90,000 -$120,000, DOE
Location: Chatsworth, CA.
Fralock is an engineered solutions provider of specialty components and subassemblies using advanced materials for high reliability, severe environment, and technically challenging applications. We develop and manufacture custom integrated solutions. Established in 1967, we are a critical solutions provider to Fortune 500 corporations, government, and targeted OEMs in a variety of industries including Semiconductor Equipment Manufacturing, Medical and Life Science, Aerospace and Defense, Industrial, Electronics, and Energy. Fralock is headquartered in Valencia, CA with manufacturing locations located throughout Northern and Southern California.
VISION
To be recognized by our customers as a leading solutions provider of proprietary engineered advanced materials for high reliability, severe environment, and technically challenging applications.
MISSION
To create value, profitably grow, and share our success with all stakeholders.
CULTURE
- Respect – We treat others the way they want to be treated.
- Integrity – We practice a high standard of ethics in our business dealings with customers, suppliers, and employees.
- Responsiveness – We have a sense of urgency in responding to internal and external requests and work proactively to solve problems.
- Excellence/Competence – We empower our people to continuously improve and execute high-quality work.
- Teamwork – We work together to achieve Fralock business objectives by communicating at a high level, by listening and having clarity in our expectations of one another.
- Individual Accountability and Personal Responsibility – We do what we have committed to do when we committed to doing it.
- Continuous Improvement across all segments of the company
Job Summary
The Senior Quality Engineer is responsible for supporting and maintaining the effectiveness of the Quality Management System (QMS) and ensuring manufacturing and quality processes comply with applicable regulatory, customer, and internal requirements This role partners closely with Engineering, Manufacturing, Operations, Supply Chain, and Customers to develop, implement, and continuously improve quality systems that support the production of high-performance composite materials and assemblies.
This position provides technical quality leadership in the areas of change control, nonconforming material and Material Review Board (MRB), metrology and calibration, risk management, and process validation. The Engineer drives a culture of continuous improvement by utilizing data-driven decision-making, root cause analysis, and structured problem-solving methodologies to identify and eliminate quality issues by means of Corrective and Preventive Action (CAPA) initiatives, utilizing six sigma methodologies as appropriate and developing/revising standardized quality procedures.
Additionally, the Quality Engineer defines and evaluates critical quality characteristics for new and existing products, processes, and materials. They analyze inspection and test data to validate product performance, assess process capability, support new product introductions, conduct internal audits, and collaborate with cross-functional teams to improve manufacturing efficiency, reduce defects, and enhance overall product reliability.
Key Responsibilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform these essential functions.
Under minimal supervision, must be able to perform a variety of job duties including, but not limited to:
- Support compliance with applicable Quality Management System requirements, including ISO 13485, ISO 9001, and/or AS9100.
- Define, interpret, and classify quality characteristics for new and existing products, processes, and services. Interprets the results of evaluations and tests used to verify and validate the design of products, processes and services.
- Initiate, review, and approve Document Change Orders and other change-control documentation to ensure changes are appropriately evaluated, documented, approved, and implemented.
- Participate in and provide Quality oversight of the Material Review Board (MRB) and the disposition of nonconforming materials, products and RMAs.
- Investigate nonconformances and support the identification of root causes, corrections, corrective actions, and preventive/systemic improvements, including Supplier Corrective Actions as needed.
- Lead and support process improvement and Six Sigma activities to improve product quality, process capability, yield, efficiency, and overall manufacturing performance.
- Manage assigned internal and external customer interface, including supporting product build issues and quality actions, new program launches, First Article Inspection (AS9102) and customer-specific quality requirements.
- Support and ensure the company's calibration program is within compliance, including inspection, measuring, and test equipment is appropriately calibrated, maintained, and suitable for its intended use.
- Partnering with internal customers and leaders to reduce scrap, rework, and process variation.
- Using data, trend analysis, and KPI’s to drive continuous improvement and work with stakeholders through the entire process to enhance Quality for our customers.
- Conduct technical/statistical studies (SPC, MSA, First Article reports, etc.).
- Develop, review, and update risk management documentation, including Process Failure Mode and Effects Analyses (PFMEA/FMEA) and associated risk-control activities.
- Develop, review, approve, and execute process validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Prepare, document, and communicate quality procedures as required to all employees
- Analyze and report findings of customer returns (RMA) and internal rejections (NCR) Issues
- Other duties as needed or assigned.
Required Skills
- Must have excellent written and verbal skills. Ability to read, analyze, and interpret general business information. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers.
- Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions.
- Ability to manage and solve problems involving a few concrete variables in standardized and complex situations.
- Ability to read and interpret engineering drawings in accordance with GD&T standards.
- Strong knowledge of quality processes within a manufacturing environment.
- Proficiency in ERP systems and Microsoft Suite for tracking, reporting, and data management.
- Must have knowledge to apply complex use of databases/spreadsheets.
- Ability to complete the planning of workflow and meetings.
- Must have solid analytical skills and solution-driven thinking. Able to use large amounts of data to make strategic decisions.
- Ability to apply continuous improvement and lean principles to enhance efficiency and productivity.
- Experience with KPI tracking, performance metrics, and data analysis to support operational improvements.
Preferred Skills
- Root Cause Analysis, SPC, Lean Manufacturing, experience utilizing Minitab.
- Six Sigma Green belt or Black Belt Certified
- ASQ Certified Quality Engineer
- Experience in aerospace, semiconductor, medical and automotive industry
Education Requirements
- Bachelors (B.S.) degree in manufacturing engineering, or related field and three (3) to five (5) years experience in a regulated environment (ISO 9001, AS9100, and/or ISO 13485).
- Minimum of three (3) years of quality engineering experience.
- Experience managing ERP systems (e.g., Made-2-Manage).
- Experience with ISO 9000, AS9100, and/or ISO 13485 Standards.
Physical Requirements
- Frequent use of hands for handling equipment and tools.
- Ability to perform similar operations and tasks for 6-8 hours.
- Ability to sit and stand for 6 to 8 hours.
- Ability to lift up to 25 lbs. frequently
- Ability to lift, push and pull up to 50 lbs. occasionally.
- Ability to bend and reach for 6 to 8 hours.
Working Conditions
- Work performed indoors in a temperature controlled environment frequently.
- Required use of PPE including safety glasses, gloves, and safety‑toed footwear.
- While performing the duties of this job, will regularly be exposed to moving high-speed machinery and mechanical parts. Will occasionally be exposed to machine oils and hazardous materials.
- Travel 10% as required.
All offers of employment at Fralock are contingent upon clear results of a background check. Background checks may include some or all the following depending on job title and responsibilities:
- Social Security Verification
- Prior Employment Verification
- Criminal History
- Personal and Professional References
- Motor Vehicle Records
- Credit History
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of a position. #ZR
Fralock Fremont, California, USA Office
46211 Research Avenue, Fremont, United States, 94539
Fralock Milpitas, California, USA Office
311 Turquoise Street, Milpitas, United States, 95035
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