Quality Engineer

B & M Precision Inc • Ruskin, FL

13d • Onsite

About The Position

B&M Precision is an FDA-registered and ISO 13485–certified medical device contract manufacturer committed to producing safe, compliant, and high-quality products. Our quality culture is grounded in robust processes, data-driven decision-making, and continuous improvement. We are seeking a Quality Engineer who will help maintain certification, strengthen system effectiveness, and partner with operations to continuously improve product and process quality. This is not a remote position.

The Quality Engineer is responsible for supporting, maintaining, and improving an ISO 13485–compliant Quality Management System (QMS). This role ensures manufactured products meet all applicable regulatory, customer, and internal requirements through effective process control, risk-based decision-making, and cross-functional collaboration. The position combines hands-on manufacturing quality support with ownership of key quality system processes.

Requirements

• 5+ years in inspection and quality assurance (medical device, aerospace, automotive, or machining preferred)
• 3+ years in document control within FDA-regulated environments and knowledge of ISO 13485
• Demonstrated success improving quality systems and reducing nonconformances
• Strong working knowledge of advanced metrology tools: Micro-Vu, Keyence, Optical Comparators, calipers, micrometers, gage pins, and more
• Proficiency in MS Office Suite, Adobe Visio, PowerPoint, and advanced Excel (PivotTables, VLOOKUP, Data Analysis)
• Independent, self-driven leader capable of managing projects, timelines, and control plans
• Excellent verbal and written communication—able to lead training, write reports, and engage stakeholders effectively

Responsibilities

• Maintain and improve the effectiveness of the ISO 13485–certified QMS.
• Ensure ongoing compliance with applicable FDA 21 CFR Part 820 requirements.
• Support internal audits, supplier audits, and external audits (certification, customer, and regulatory).
• Review, revise, and improve SOPs, Work Instructions, and quality records to ensure clarity, compliance, and effectiveness.
• Provide data, metrics, and objective evidence to support Management Review.
• Monitor, analyze, and trend internal and external nonconformances.
• Lead root cause investigations using structured problem-solving methodologies.
• Initiate, manage, and verify the effectiveness of corrective and preventive actions (CAPA).
• Facilitate regular CAPA review meetings and ensure timely closure.
• Drive continuous improvement initiatives using quality data, risk analysis, and performance metrics.
• Ensure inspection criteria and acceptance requirements are clearly defined and accurately reflected on engineering drawings, routers, and inspection plans.
• Support Engineering Change Orders (ECOs), Engineering Change Requests (ECRs), and Document Change Requests (DCRs).
• Partner with Manufacturing and Engineering to resolve quality issues and improve process capability.
• Support first article inspections, process validations, and change impact assessments as required.
• Ensure inspection and measurement methods are appropriate, repeatable, and reliable.
• Lead or support GR&R studies and measurement system analyses (MSA).
• Maintain confidence in inspection results through proper use of calibrated and verified metrology equipment.
• Train Quality and Production personnel on inspection techniques, GD&T interpretation, and metrology best practices.
• Support supplier qualification, monitoring, and re-evaluation activities.
• Lead or approve supplier audits and supplier corrective actions.
• Analyze supplier performance data and work with suppliers to drive improvement.
• Provide quality-related training to internal personnel as required.
• Communicate quality trends, risks, and improvement opportunities to cross-functional teams.
• Act as a quality liaison between Manufacturing, Engineering, Supply Chain, and Management.

Benefits

• Excellent medical, dental and vision benefits after 60 days; 100% paid for employees and 75% paid for dependents.
• Paid vacation, PTO and 8 paid holidays
• Annual performance bonus
• Profit sharing and matching 401K

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level