Top 12 Quality engineer medical device Jobs in Petaluma, Ca

Manufacturing Quality Engineer
Collidion —Petaluma, CA
- Full-time
- Mid-level
- 3 years
- Master's degree
Quality Engineer
Abbott Laboratories —Santa Rosa, CA
- $90,000 - $180,000 a year
- Full-time
- 5 years
- Bachelor of Science
- Experience equivalent to degree accepted
- Health insurance
- Tuition reimbursement
Reliability Engineer - Compound Semiconductor ICs
Keysight Technologies, Inc. —Santa Rosa, CA
- $138,960 - $231,600 a year
- Full-time
- Bachelor of Science
- Office
- Analysis skills
- Health savings account
- Employee stock purchase plan
3d
Design Engineer - Bioprocess Components
IDEX Health & Science LLC —Rohnert Park, CA
- $109,800 - $164,600 a year
- Online Application
- Mid-level
- Analysis skills
- Manufacturing
- Health insurance
- Paid time off
In-Fab Wafer Test Engineer
Keysight Technologies, Inc. —Santa Rosa, CA
- $93,050 - $155,080 a year
- Full-time
- Software troubleshooting
- Analysis skills
- Continuous improvement
- Health savings account
- Employee stock purchase plan
R&D Engineer 3, Hardware
Keysight Technologies, Inc. —Santa Rosa, CA
- $106,130 - $176,880 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Doctor of Philosophy
- Health savings account
- Employee stock purchase plan
7d
Sr. R&D Engineer
Endologix —Santa Rosa, CA
- $100,000 - $115,000 a year
- Full-time
- Engineering
- 11+ years
- Master's degree
- Commuter assistance
- Health savings account
Semiconductor Die Fab Process Engineer
Keysight Technologies, Inc. —Santa Rosa, CA
- $103,850 - $173,080 a year
- Full-time
- Bachelor of Science
- Assembly
- Analysis skills
- Health savings account
- Employee stock purchase plan
Principal R&D Engineer
Endologix —Santa Rosa, CA
- $145,000 - $167,500 a year
- Full-time
- 6 years
- Master's degree
- Doctor of Philosophy
- Commuter assistance
- Health savings account
Chief RF Engineer
Emerson —Santa Rosa, CA
- $180,872 - $248,700 a year
- Full-time
- Hybrid work
- Master's degree
- Doctor of Philosophy
- Travel
- Profit sharing
- Paid parental leave
Principal Design Assurance Engineer
Endologix —Santa Rosa, CA
- $135,000 - $157,500 a year
- Full-time
- Engineering
- Product management
- Experience equivalent to degree accepted
- Commuter assistance
- Health savings account
Tooling Engineer III
SMC Ltd. —Santa Rosa, CA
- $86,000 - $135,000 a year
- Full-time
- Background check
- Engineering
- Pass drug screening
- Paid holidays
- Disability insurance
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12d

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quality engineer medical device jobs near petaluma, ca

Manufacturing Quality Engineer

Collidion -
Petaluma, CA

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Job Details

Full-time

Qualifications

PLC-based control system operation
Statistics
ISO standards
Quality control statistical data analysis
Statistical Process Control
CAD design (engineering design task)
FDA 21 CFR Part 11
Minitab
Design controls
Biomedical regulatory compliance
Productivity software
Statistical analysis tools

Full Job Description

Full-Time

Petaluma, CA

DESCRIPTION

This position reports to the Director of Quality and supports the manufacturing quality activities by complying with GMP requirements. The incumbent is responsible for verification, validation, qualification, implementation of manufacturing process equipment, and the following duties:

Provides leadership in developing processes, methods, and criteria for inspections (incoming, in- process, and final product).
Reviews controlled documents including batch records, QC data, results, and master batch record for accuracy.
Identifies and develops new quality metrics as needed
Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis, and CAPA.
Installation and validation of rapid automation-based process equipment (robotic systems).
Responsible for inspection, test and calibration operations
Performs calibration (Gauges, Timers, Meters, Calipers) of tools and equipment; conducts tests on installed automation-based process equipment (robotic systems).
Initiates, and reviews change orders, deviations, and manages control of non-conforming products.
Develops engineering specifications, sampling plans, test protocols, manufacturing floor process flows, work instructions, test methods, master validation plans, and performs any other quality related activities as assigned.
Determines conformance of products by following internal procedures and Quality System Regulation.
Regularly monitors product quality by gathering and maintaining manufacturing quality metrics.

EDUCATION REQUIREMENTS

Master’s degree in Mechanical Engineering with minimum of 3 years of experience in manufacturing environment or Bachelor’s degree in Mechanical Engineering with 5 years of experience in manufacturing environment.

ADDITIONAL EXPERIENCE REQUIREMENTS

Experience in manufacturing/production and process control in a regulated industry (Pharmaceuticals, Medical Devices, Cosmetics or Dietary Supplements) highly preferred.
Good understanding of 21CFR part 820, part 700, part 11, GAMP, ISO 9001, ISO 13485 and ISO 14971.
Familiarity with automations systems, and PLC; Gage R&R, FMEA.
Sound knowledge of Quality Control, Statistical Process Control, & Capability Analysis and tools.
Proficiency in Minitab, Microsoft Office Suites and CAD Software/Solid Works.
ASQ-CQE is desirable but not required.
Knowledge of product inspection standards and sampling, advanced manufacturing, quality assurance, and pharmaceutical product development.

OTHER QUALIFICATIONS

Detail oriented with well-developed organizational and analytical skills.
Ability to work in a team environment and positive attitude is a plus.
Experience working in a fast-paced, start-up environment is a plus.

Collidion is an equal opportunity employer.

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Refine Your Search

quality engineer medical device jobs in petaluma, ca

Manufacturing Quality Engineer

Quality Engineer

Reliability Engineer - Compound Semiconductor ICs

Design Engineer - Bioprocess Components

In-Fab Wafer Test Engineer

R&D Engineer 3, Hardware

Sr. R&D Engineer

Semiconductor Die Fab Process Engineer

Principal R&D Engineer

Chief RF Engineer

Principal Design Assurance Engineer

Tooling Engineer III

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Full-Time

Petaluma, CA

DESCRIPTION

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