Quality Director (ISO 13485)

Balda-C-Brewer; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Balda-C-Brewer in Ontario, CA seeks a Quality Director (ISO 13485) to lead the quality department and maintain compliant QMS across ISO 9001, 13485 and FDA 21 CFR 820.

The role directs validation, change control, CAPA, metrology, audits, supplier quality, and customer complaints while driving continuous improvement and training across site personnel.

Qualifications

• 5+ years leading quality systems in pharma or medical devices.
• Strong knowledge of ISO 13485 and 21 CFR 820 compliance.
• Experience with validation, metrology, poka-yoke and inspection tooling.
• Demonstrated ability to train and develop staff.

Responsibilities

• Lead and maintain an effective QMS aligned with ISO 9001/13485 and FDA rules.
• Oversee validation, change control, CAPA, and nonconforming product handling.
• Direct audits, vendor quality, customer complaints and continuous improvement.
• Manage department resources, budgets, and cross-functional coordination.
• Develop training programs and lead strategic quality initiatives.

Skills

Leadership

ISO 13485

FDA 21 CFR 820

Quality Planning

CAPA Management

Metrology & Inspection

Training & Development

Six Sigma

Auditing

Process Improvement

Education

Bachelor’s degree in sciences/engineering

Tools

IQMS

PC-DMIS

Minitab

Job description

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Quality Director (ISO 13485)

Full Time Management Ontario, CA, US

Salary Range: $140,000.00 To $190,000.00 Annually

Responsible to manage, promote, and continuously maintain a compliant quality management system by effectively managing the quality department that consist of validation, quality inspection, document control, change control, customer complaints, metrology, CAPA management, nonconforming product, calibration, receiving inspection and product release activities. As a quality manager you will ensure that the manufacturing site meets and applies the Global Quality Policies and Guidelines relating to, ISO 9001 & 13485 standards, FDA 21 CFR 820 regulations, customer requirements and comply with necessary local and international regulations.

Essential Job Functions and Responsibilities:

• Responsible for , leading developing, implementing and manage an effective quality management systems that supports the company-wide quality policy, ISO 9000, ISO 13485 and FDA 21 CFR 820 regulations for medical devices with a continuous improvement programs.
• Lead, develop, implement and maintain quality systems for controlling product quality using process capability, inspection, auditing and statistical analysis.
• Lead, develop, implement and maintain an effective quality system for preventing nonconforming product and/or its recurrence using quality planning, material review, corrective action and quality reporting.
• Responsible for selection, interviewing and onboarding of new hires and develop a relevant training program and plan for all site personnel.
• Responsible for leading, driving and enforcing quality programs in collaboration with manufacturing team.
• Resolve customer concerns, complaints and provide feedback on quality issues.
• Analyze daily and monthly quality reports and develop tests to improve product quality.
• Support company quality policy and objectives.
• Ensure products produced meets customer expectations (approve quality specifications) and regulatory requirements
• Lead customer audits, ISO audits and Internal audits
• Achieve financial objectives (maintain department salaries within budget, prepare the Quality budget, schedule the expenditures)
• Follow and report of the site quality performances from a quality standpoint and ensure alignment with Business Unit and manage continuous improvement for product quality
• In cooperation with the Sites Quality Coordinator, develop and implement Quality Objectives in line with objectives of the business unit
• Lead and influence a quality mindset to quality and operations to maintain, improving and maintaining quality system requirements.
• Continually improve quality through analyzing, identifying, and eliminating root causes. Such improvements include reducing defects, decreasing scrap, reducing waste, and improving outputs.
• Apply and evaluate testing and inspection methods; including the identification of requirements for improvements.
• Develop and implement quality cost reduction concepts and techniques.
• Manage department resources, including work assignments, training, cross training, personnel issues, hiring decisions, performance appraisals, motivation, efficiency, capacity and accuracy of work.
• Ensure shift-to-shift communication.
• Provide a safe work environment and resolve any safety issues that arise.
• Perform other job-related duties as assigned.

Core Competencies:

• Facilitation
• Conflict Management
• Information Gathering & Processing
• Interactive Communication
• Partnering
• Relationship Building
• Research
• Teamwork
• Writing Skills
• Concern for Safety
• Proactive and self-motivated
• Strong time management with priority setting skills
• Client focused

Knowledge, Skills, and Abilities:

• Expert knowledge and interpretation of ISO 13485, ISO 9000 standards, 21 CFR 820 and cGMP compliance.
• Ability to lead, implement quality management systems as applicable to ISO and 21 CFR regulations.
• Demonstrate understanding of industry standard validation tools and techniques.
• Demonstrated ability of metrology and basic inspection tools, metrology and injection molding workmanship standards.
• Ability to develop/conduct quality related training programs.
• Effectively communicate in both verbal and written.
• Good organizational skills.
• Excellent English communication skills (both written and verbal).
• Fluency in Spanish a plus.
• Understanding and use of metrology equipment.
• Ability to read drawings and good understanding of geometric tolerancing.
• Knowledge of processing engineering polymers is a plus.
• Exceptional leadership skills which include ability to prioritize, lead, direct, train, and motivate staff.
• Ability to influence peers.
• Excellent planning and organizational skills.
• Good analytical, problem-solving and math skills. Six Sigma and Lean knowledge a plus.
• Understanding and use of sampling plans, Gauge R&R, statistical techniques and SPC.
• Ability to use personal computer and Windows-based software (Outlook, Word and Excel preferred). Use of PC-DMIS metrology software, IQMS manufacturing software and Minitab a plus.

Education and/or Experience:

• Bachelor’s degree desirable, four-year college degree (preferably in a sciences chemical, pharmacy, plastics or engineering field) or equivalent combined college/work experience.
• At least 5 years of leading and implementing quality systems in a pharmaceutical or medical device environment
• Manufacturing experience in injection molding plastics industry (or equivalent industry) is a plus.