Senior Quality Control Inspector
About The Position
Are you a detail-driven professional with a passion for quality? We are seeking a Senior Quality Inspector to join our team! As a key member of the Quality team, you will play a critical role in ensuring that our products meet the highest standards of safety, effectiveness, and compliance. The Senior QC Inspector will be a hands on individual that will perform inspection and testing of incoming materials, in-process samples and finished products to ensure the materials and products conform to specifications and requirements. Communicate with team and management promptly on quality related issues. Initiate Non-conformance Report (NCR) and assist with the calibration and preventive maintenance program of equipment/instruments. Location: This is an onsite position located at our Santa Ana, CA office. Candidates living within a 25 mile range preferred.
Requirements
- High school Diploma or equivalent required. Associate degree or higher preferred.
- A minimum of 8 years of inspection and testing experience in GMP environment, preferably in the medical device or pharmaceutical industries, is required.
- Proficient in a wide range of dimensional inspection techniques/equipment (caliper, micrometer, drop indicator, pin gauge, CMM, Keyence, optical inspection system) with good hand eye coordination and high manual dexterity.
- Contribute to and support the development of accurate and rugged inspection procedures.
- Able to clearly describe and convey nonconformance issues.
- Experienced in a fast-paced environment and able to balance and prioritize workload to support production schedule.
- Ability to train others in methodology and procedures.
- Ability to serve as a role model to other workers/colleagues in proper execution of day-to-day inspection duties as well as a guide in the understanding of operations and quality standards.
- Proficient computer skills in Microsoft Office Excel and Word, manufacturing software, QMS software, etc.
- Must be hands on and ability to as needed perform physical work pertaining to inspection
- Tech-savvy and able to learn new software quickly.
- Ability to gets things done without perfect resources, is innovative, and works with a sense of urgency.
- Ability to be flexible and willing to do what it takes to support company and department goals.
- Results oriented – drives progress & excellence.
- Ability to work independently with minimal supervision.
- Effective interpersonal and communication skills.
- Well organized and attentive to details.
- Contributes to a collaborative and inclusive work environment.
Nice To Haves
- An individual with high standards, takes ownership, and is invested in the outcome, is perferred.
- Ability to be proactively helps others, stays positive and has a good sense of humor.
Responsibilities
- Perform visual, dimensional, and functional inspections and/or testing across all components, subassemblies and finished medical device products using all applicable tools and equipment to ensure conformance with design specifications.
- Archiving receiving inspection and other QC records in Oracle PLM.
- Perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
- Ensuring all necessary samples are pulled and tested per procedures requirement.
- Determine acceptability and/or identify defective raw materials and finished products following established procedures and specifications.
- Provide immediate feedback to production line and immediate leadership on all quality related problems.
- Support the calibration and preventive maintenance program.
- Initiate Non-conformance Report (NCR) as needed.
- Additional projects and/or duties as assigned
Benefits
- Company provided lunch to all employees when working at one of AMDI’s on-site locations.
- 401(k) match
- Health insurance, 100% paid for by employer including: Medical, Dental, Vision & Life Insurance
- Competitive vacation, sick days & paid holidays
- Tuition reimbursement
- Casual dress code
- Employee discounts on activities such as theme parks, movie theaters, hotels, rental cars, etc.
- Monthly company-wide socials and activities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
