Benefits:

401(k)

401(k) matching

Relocation bonus

JOB TITLE: Senior Quality Engineer (SQE)

JOB FUNCTION: Quality Management

Location: Milpitas, CA

Summary:

Responsible for ensuring that materials, goods and services meet Customer and Quality

requirements. Maintains the Quality System to comply with regulatory requirements.

Leads continuous quality improvement activities. This is a hands on position that works

with Customers and all functions and levels within the company

Job Description:

 Quality Management System

o Maintain the Quality Management System procedures and work

instructions to comply with Customer and Quality/Regulatory requirements

o Work with all functions to ensure compliance with requirements

 Supplier Management

o Manage the Supplier Management program

o Initiate Supplier Evaluations and perform Supplier Approvals

o Conduct Supplier Audits

o Maintain the Approved Supplier List

o Develop Supplier Quality Measures and work with Suppliers to improve

performance

o Maintain an effective Supplier Corrective Action process

o Identify opportunities for supply chain improvements. Implements process

improvement to increase quality and yields at suppliers

 NCMR

o Manage the Non Conforming Materials Process

o Works with Customers, Suppliers and internal personnel to resolve

nonconforming materials issues

o Prepare non-conforming material reports and participate in subsequent

root cause investigation and corrective action planning.

 Incoming Inspection

o Participate with, and supports the Incoming Inspection function

o Develops Incoming Inspection requirements

 Manages the Calibration and Preventive Maintenance process

o Coordinates the calibration of equipment with the Calibration Service

o Works with personnel and Customers to ensure that all equipment is

calibrated and maintained

o Ensure that all internal calibrations are performed per requirements

P/N: 7700-0057 Rev D Page 2 of 3

DCR: 001765

 Participate on New Product Introduction teams to ensure customer and

regulatory requirements are met

 Manage the Corrective & Preventive Action System including responding to

Customer Complaints

 Develops and prepares QMS metrics to monitor the performance of internal

processes for Customers, and Management

 Manage the Document Control process for Quality Management System

documentation

 Prepare materials for, and participates in Management Reviews

 Facilitate the Internal Audit program and conduct audits of the QMS

 Facilitate and manage Customer, Notified Body, and Regulatory Audits

 Work with all functions to ensure Training is conducted per requirements

 Performs Release to Finish Goods and Authorizations for Distribution

 Drives improvements by facilitating cost and quality improvement projects

Knowledge and Skills:

 Demonstrated ability to work well in a cross-functional team environment and

clearly communicate status of assigned projects.

 Ability to work under tight deadlines and to handle multiple detail-oriented tasks

simultaneously

 Excellent oral, written and people skills.

 Demonstrated high level of computer literacy - proficient in developing

spreadsheets, utilizing word processing and databases (MS Office)

 Proficient in performing Corrective and Preventive Actions

 Proven analytical ability and attention to detail.

 Ability to work proactively with suppliers to improve product quality and quickly

resolve quality issues

 Understand and be proficient in the use of incoming inspection equipment.

 Knowledge of theory and application of principles of statistics, statistical sampling

techniques and statistical process control.

 Knowledge of, and experience with sterile medical device controls and

requirements would be a benefit

Education and Experience

 Bachelor degree in Engineering, prefer Industrial, Manufacturing or Mechanical

 5 plus years of Quality Engineering experience

P/N: 7700-0057 Rev D Page 3 of 3

DCR: 001765

 Required Medical Device Experience

 Comprehensive knowledge of ISO 13485 and 21CFR820

 Auditing experience required

In addition experience with the following would be beneficial:

 Contract Manufacturing

 Lean Manufacturing

 Process Validations

 Software Validation

 Risk Management

 AS9100

 ITAR

 RoHS