Quality Engineering Manager

Arena Direct Hire has partnered with an established, growth-oriented medical device manufacturer in North County San Diego that is hiring a Quality Engineering & Quality Control Manager. This position will work onsite five days a week within a fast-paced manufacturing and machine shop environment.

This is a hands-on leadership opportunity for an experienced quality professional who can manage Quality Engineering and day-to-day Quality Control operations while strengthening inspection systems, calibration programs, supplier quality, process controls, and new product development activities.

Why you will want this role:

• Leadership ownership: Oversee both Quality Engineering and Quality Control operations.
• Product impact: Support the quality requirements for existing and newly developed medical devices.
• Process improvement: Implement controls that improve product quality, operational performance, and manufacturing costs.
• Cross-functional exposure: Partner with manufacturing, engineering, regulatory, suppliers, and other key teams.
• Established organization: Join a stable, regulated manufacturer with a meaningful Southern California presence.
• Competitive benefits: Medical, dental, vision, 401(k) matching, and additional voluntary benefits.

What you will own:

• Lead the Quality Engineering function and establish Quality Control priorities.
• Develop quality plans, inspection processes, sampling procedures, and inspection requirements.
• Validate inspection methods, equipment, and automated inspection systems.
• Support new product development through drawing reviews, risk assessments, quality planning, and validation activities.
• Manage calibration programs for measurement devices, gauges, and inspection equipment.
• Analyze nonconforming products, complaints, operational performance, and quality metrics.
• Support supplier onboarding, evaluations, review activities, and audits.
• Train Quality Control personnel on inspection requirements, procedures, and product characteristics.
• Support internal audits and inspections conducted by customers, consultants, and regulatory authorities.
• Implement quality improvements and process controls across manufacturing operations.

Must-have requirements:

• 8 to 10 years of Quality Engineering or Quality Control experience within medical devices or another FDA-regulated manufacturing environment.
• Experience leading Quality Engineering and Quality Control operations.
• Strong knowledge of inspection systems, sampling procedures, validation, calibration, and process controls.
• Experience supporting new product development and manufacturing validation activities.
• Experience with supplier quality, supplier evaluations, and audits.
• Experience investigating nonconforming products and analyzing quality metrics.
• Ability to succeed in a fast-paced manufacturing or machine shop environment.
• Strong leadership, communication, organization, problem-solving, and follow-through skills.
• Working knowledge of Microsoft Office, Adobe, and ERP systems.
• Ability to work onsite five days a week in North County San Diego, with occasional travel to other facilities.

Nice-to-have requirements:

• Experience with automated inspection equipment and programming oversight.
• Knowledge of document control systems.
• Experience within a high-volume precision manufacturing or machine shop environment.

Compensation:

$125,000 to $138,000 annually, depending on experience and qualifications.

Arena Staffing and our client are equal opportunity employers. Qualified applicants are considered for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, or any other protected status under applicable law. Reasonable accommodations are available throughout the hiring process.