BOLT Staffing
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http://www.boltstaffing.com
http://www.boltstaffing.com
USD
37.00
38.00
HOUR
true
Natalie Rivera
Manufacturing Quality Engineer
Job Description
Manufacturing Quality Engineer
Job Location: Petaluma, California
Job Type: Temporary
Pay Rate: $37-$38/hour
Schedule: Monday - Friday, 8am-5pm
Description of Position:
Are you an experienced Manufacturing Quality Engineer seeking a new assignment in Petaluma, California? Our client is seeking an experienced candidate to work directly with the Director of Quality, this role supports the manufacturing quality activities by ensuring compliance with GMP requirements. You will be responsible for the verification, validation, and implementation of manufacturing process equipment, while also performing a range of essential quality-related duties.
Key Responsibilities include:
- Provide leadership in developing processes, methods, and inspection criteria for incoming, in-process, and final products.
- Review controlled documents such as batch records, QC data, and master batch records for accuracy.
- Resolve production and manufacturing issues using quality tools like root cause analysis, statistical analysis, and CAPA.
- Oversee installation and validation of automation-based process equipment (robotic systems).
- Perform calibration of tools and equipment such as gauges, timers, meters, and calipers.
- Initiate and review change orders, deviations, and manage non-conforming products.
- Develop engineering specifications, sampling plans, test protocols, and manufacturing floor process flows.
Description of Company:
You will be supporting a well-established pharmaceutical company based in Petaluma, California. This company is committed to improving the future of global health by delivering innovative solutions to address critically unmet medical needs.
Experience Required:
- 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.
- 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.
Similar Positions:
Quality Assurance Engineer
Process Validation Engineer
Quality Control Specialist
Supplier Quality Engineer
Bolt Staffing is an equal opportunity employer. Applicants of all backgrounds are encouraged to apply. We understand that you might not meet every requirement for this position, but we encourage you to apply even if you do not "Check all the boxes."
For inquiries about this position or to explore other job opportunities at Bolt, feel free to contact us at the following numbers:
- Stockton - (209) 307-6115
- American Canyon - (707) 552-7800
- Sonoma - (707) 939-2800
Meet Your Recruiter
Natalie Rivera
Staffing Coordinator
Natalie is a bilingual recruiter based in our Sonoma office. Around the office, she is known for her supportive attitude, impeccable handwriting, and perpetual desire for a Chick-fil-A sandwich. When she is not at work, Natalie loves to visit different California hiking destinations.
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About Petaluma, CA
Ready to embark on a rewarding career journey in Petaluma, California? Discover exciting job opportunities in this vibrant city known for its picturesque landscapes, historic architecture, and thriving arts scene. Nestled in Sonoma County, Petaluma offers a perfect blend of small-town charm and big-city amenities. From the iconic Petaluma River and Helen Putnam Park to the renowned Petaluma Arts Center and Cinnabar Theater, this region boasts a unique cultural flair that sets it apart. Embrace career growth amidst charming boutiques, delectable farm-to-table dining experiences, and the enchanting local wines. Join us in exploring job listings that could redefine your future in this captivating region!