Quality Assurance Engineer Jobs

This position is located at the Tyco Electronics Tubing and Materials facility in Menlo Park, CA. Tyco Electronics is a global leader in the design, manufacture, and sale of interconnect solutions for customers in many industries with demanding, diverse requirements. We are seeking Quality Engineer candidates with prior quality engineering experience, particularly in the Medical Device industry, to assist in the accelerated development of Medical Device products at this facility.

The Quality Engineer is responsible to plan, direct, and perform activities that:

1. Assure the dimensional, material and visual characteristics of the product's design, as documented on drawings, specifications and quality standards, are consistently produced, and that products of acceptable quality are delivered to the customer,
2. Assure compliance to all regulatory requirements,
3. Identify opportunities to continuously improve products, service, processes, and the quality system.

• Develop procedures and systems to elevate current Quality Management System (QMS) to achieve certification to ISO 13485:2003 for planned expansion into the production of Medical Components/Devices.
• Develop, perform, and document process validation plans and perform IQ/OQ/PQ qualifications on tooling.
• Develop, perform, and document product qualification plans to ensure GMP compliance.
• Coordinate and/or assist with customer or certification audits of the existing QMS to the requirements of ISO-9001:2000, AS9100, TS16949 (and future ISO 13485:2003) Quality Systems. Develop and implement written documents in support of the quality system requirements.
• Conduct in-process audits of manufacturing operations and processes. Participate in product validation audits performed as a result of customer complaints, requests, and source inspections.
• Perform, coordinate, and participate in root cause analysis and corrective action determination to provide resolution to customer complaints, quality system audit improvement notes, non-conforming material disposition, and process variation.
• Direct the review of customer specifications to determine compatibility with Tyco Electronics production drawings and manufacturing processes. Review customer supplied documentation to assure compliance to customer quality specifications, certification, tests and other contractual and regulatory requirements.
• Define control points, inspection methods, and intervals within the manufacturing processes and implement them through the use of detailed Quality Inspection Plans and Test Requirements.
• Coordinate the disposition of non-conforming material, notification of rejection, and requirements for corrective action to the source responsible for the non-conforming condition. Review inspection and test data, quality audits, customer audits, disposition summaries and report findings to Quality and Operations Management.
• Determine quality capabilities and continuous improvement strategies for machines and processes by leading Design and Process Failure Mode Effects Analysis' (FMEA's). Effectively apply techniques like DOE and SPC to drive process improvements.

SSI Technologies, Inc. is a world-class manufacturer of sensors, powder metal products and other components for the automotive industry and industrial applications has an immediate opening for a Quality Engineer.

SUMMARY
Reporting to the Quality Manager, assists in the management of the Quality function for the Janesville Plant. Responsible customer satisfaction, internal defects, scrap performance, and financial performance. Administers all ISO9000 and ISO 14001 elements and APQP functions, which fall under the Quality function.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:

1. Identifies, prevents, and analyzes defects, both internal and external. Tracks internal and external defects and reports this information for the purpose of 8-D problem solving analysis.
2. Coordinates the 8-D problem solving for products manufactured within specified assignments.
3. Participates in and contributes to the development of PFMEA, C-plans, P-flows, test plans, and deviations.
4. Reduce uncertainty in measurements and participates in and is accountable for gage capability, calibration, and statistical methods.
5. Revises and maintains the Statistical Process Control system.
6. Coordinates PPAP submissions to customer.
7. Participates in the control of internal and external component vendors.
8. Evaluate the capabilities of Quality Technicians, provide leadership, and provide/coordinate education and training to keep personnel focused on continuously improving.
9. Maintain compliance to current ISO standards and customer specific requirements as applicable.
10. Support, promote, and perform in a manner consistent with High Performance teams, continuous improvement goals, and values of SSI Technologies, Inc.
11. Perform routine calibration of gages and testing of product when needed.
12. Develop inspection criteria and control plans
13. Perform Internal Auditing functions.
14. Prevent and respond to safety challenges.

EDUCATION AND EXPERIENCE
Ideal candidate will have a Bachelors (B.S.) and/or a minimum of 3-5 years related work experience. Problem solving skills is essential to this position. Automotive and electrical knowledge in a high-volume production environment is preferred. Experience in lean manufacturing concepts is a plus.

SSI Technologies, Inc. offers a competitive benefits package.

Job Summary:
Responsible for all the quality assurance functions in the plant by working closely with the quality assurance manager and independently as needed. This position requires the ability to work on multiple projects with changing priorities.

Duties and Responsibilities:

• Chairs material review board (MRB) in analyzing and resolving quality issues – internal, supplier and external
• Leads the plant in training and development to meet product and process quality standards.
• Actively works with Director of QA Manager to meet company cost of quality and other key performance metrics.
• Responsible for implementing plant corrective/preventive action(s) (internal and external) through root cause analysis (8D problem solving)
• Leads the engineering, quality and manufacturing/process team members in the development of advanced product quality and control plans on new and existing products/processes.
• Plans and develops FMEA’s, PPAPs and Control Plans
• Responsible in the implementation of statistical process controls (SPC)
• Develops and implements scientific sampling techniques to determine product/process acceptability.
• Reviews engineering change proposals and implements the appropriate controls in meeting the requirements.
• Actively participates in enhancing product/process quality and reducing cost by working closely with the Director of QA manager and other department heads.
• Maintains quality information databases as needed.
• Serves as an internal auditor for the plant quality systems