Sr. Quality Engineer

Location
Redwood City, CA, United States
Posted
Jan 29, 2021
Ref
373517
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
As Sr. Quality Engineer Team Member, you will be in charge of client-facing engineering solution development and implementation.

Responsibilities range from:

Participate as Sr. QE in client-facing projects

Collect and define project requirements and develop solutions

Advise clients on QE concepts, principles, and practices related to the companies solutions and products.

Support Design Control, Risk Management Efforts

Ability to Support Software Development efforts a plus

Leverage the internal team to maximize efficiency on projects

Work closely with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake-Proofing, etc.)

Review/approve manufacturing and inspection tool design and related system documentation

Review/approve product and process change control documentation and specifications.

Participate in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ & PQ)

Work with manufacturing to develop process control and manufacturing metrics.

Continual assessment of current client systems and making appropriate recommendations for change, taking into considering the client's goals, business stage, and the budget

The role includes informing the client of the risks associated with any decisions they intend to make with respect to their quality system and work with the risk that the client is willing to assume in the deployment of their system.

Participate in internal and client-facing projects from the initial requirements phases through to the QA and deployment phases

Conduct or assist with complaint handling, including device failure investigation, documentation, file review, and reportability evaluation

Help develop methodologies from existing ideas and develop new ideas based on experience and contact with the client and prospect base.

Additional Responsibilities include but are not limited to:

Design Assurance

Ensure design controls in product development and improvement project activities, including risk management, design reviews, tagging/tracking, non-product tools validation, and product/process validation

Author and/or review design input/output/verification/validation documents as appropriate

Author and/or review documents for 510(k)s

Work with R&D on Technical File for CE Marking

Work with R&D on EMC and safety (UL/CSA) certification

Audit DHF

Manufacturing QA

Review activities for receiving inspection, device history records, component release, and process validation

Review and approve DMR, DHR, and Validation Protocols and Reports related to processes, equipment, facility, and computer systems

Interface with Operations to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training

Manage the equipment calibration program

Sterilization and Biocompatibility QA

Establish, monitor, and maintain EO sterilization program

Conduct product biocompatibility testing

CER

Establish, monitor, and maintain CER program

EDUCATION:

Bachelor's Degree in engineering/scientific discipline

CQE, RAC, RAB, or other quality and regulatory certificates are beneficial

EXPERIENCE REQUIREMENTS:

5+ years of in-depth Quality System Implementation in compliance with FDB, FDA, and ISO 13485

Experience with the R&D lifecycle with emphasis on the QE aspects

Knowledge of statistics and application of statistical methods

Experience in a medical device company is desirable. Understanding of US FDA Quality System Requirements, ISO/EN 13485:2003, and MDD requirements is desirable

Additional Qualifications:

Quick to learn

Positive, results-oriented, and energetic team player

Excellent analytical and problem-solving skills

Excellent interpersonal and communication skills

Ability to work independently and collaboratively

Ability to prioritize and manage to critical project timelines in a fast-paced environment; must be able to handle multiple responsibilities concurrently

Must be organized, have an eye for detail, and be able to put ideas into a tangible form

A logical and organized thought pattern

Ability to follow established policies and procedures and comply with regulatory requirements

Ability to deal with unresolved situations, frequent changes, delays, or unexpected events

Ability to point out issues so that they are appropriately addressed

**no relocation reimbursement**

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin