Senior Quality Engineer - Medical Industry

Benefits:

• 401(k)
• 401(k) matching
• Relocation bonus

JOB TITLE: Senior Quality Engineer

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