Overview
Quality Control Inspector – Jewelry Jobs in Rancho Cucamonga, CA at M & G Jewelers
Fortis is a global leader in life sciences and diagnostics reagents and solutions. We partner with our customers to design, validate, and manufacture solutions to solve their complex development problems. Our teams work together across various sites, functions, & scientific disciplines to help our customers bring their innovations to market with confidence.
The Quality Engineer II is responsible for developing, coordinating, implementing, and maintaining quality processes for the manufacture and distribution of products, including both contract-manufactured and corporate-owned items. This role ensures compliance with company policies, ISO13485, 21 CFR Part 820, and other applicable regulations.
Key Responsibilities
Quality System Compliance & Process Management – Implement and maintain a Quality Management System (QMS) in compliance with FDA, ISO, and international regulations, ensuring effective change control, CAPA, and complaint handling. Lead investigations into compliance issues and provide GMP training and mentorship.
Product & Supplier Quality Management – Oversee Design Control, reviewing and approving technical documentation. Conduct risk assessments (ISO14971, FMEA) and manage supplier audits, corrective actions, and complaints resolution. Ensure smooth technology transfers for internal and contract-manufactured products.
Audits & Regulatory Compliance – Conduct internal, supplier, and external audits (ISO, FDA, customer audits). Support regulatory initiatives and management reviews by gathering and analyzing compliance data.
Document Control & Records Management – Maintain quality and regulatory documentation, including Document Change Orders (DCOs). Enhance records retention, training cycles, calibration, and preventive maintenance to optimize efficiency.
Production & Validation Support – Support product release and validation activities, including reviewing batch records, IQs, OQs, PQs, and validation master plans. Analyze test data and provide actionable recommendations to improve quality processes.
Education & Experience
B.S. degree in a scientific or engineering discipline, or equivalent experience.
3 years of experience in medical devices or in vitro diagnostics (IVD).
Experience with ISO/EN standards, FDA, Pharma, IVDR regulations.
Strong knowledge of statistical techniques, sampling methodologies, and process control.
Experience implementing and maintaining QMS.
Hands-on experience in internal audits, supplier audits, and regulatory audits (ISO, FDA, customer audits).
Proficiency in risk assessment principles (ISO14971).
Strong collaboration skills with technical teams, manufacturing, and product development.
Experience working in fast-paced, startup environments independently with minimal supervision.
Skills & Competencies
Strong verbal and written communication skills.
Proven problem-solving, decision-making, and time management abilities.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint, Visio).
Ability to work in cross-functional teams and engage internal networks for task completion.
Ability to produce logical, complete, and accurate documentation.
What We Offer
We have an incredibly talented group of intelligent, down-to-earth individuals who are committed to developing and manufacturing only the highest quality products. Our mission: “Pursuing a Healthier World by Creating Tomorrow’s Science Today” is complemented by our core values (EXCITE):
Excellence – We believe in solving for root cause. No shortcuts, no “band-aids”
Customer First – We prioritize the experience and outcomes of our customers above all.
Integrity – We are honest and accountable, holding ourselves to a high standard of ethical conduct.
Trust – We believe an engaged, empowered team begins with a foundation of trust. We trust our team members to make the right decisions and to be driven by and evaluated on results.
Entrepreneurship – We encourage smart risk taking. We value novel mistakes in the pursuit of innovation.
Fortis is an equal employment opportunity employer. The Company’s policy is not to discriminate against any applicant or employee based on race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Fortis also prohibits harassment of applicants or employees based on any of these protected categories. It is also Fortis’ policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.
Title: Quality Control Inspector – Jewelry
Company: M & G Jewelers
Location: Rancho Cucamonga, CA
