Quality Manager

About the role

Manage, promote, and continuously maintain a compliant quality management system by leading the quality department, which includes validation, quality inspection, document control, change control, customer complaints, metrology, CAPA management, nonconforming product, calibration, receiving inspection, and product release activities.

Ensure the manufacturing site meets and applies Global Quality Policies and Guidelines, ISO 9001 & 13485 standards, FDA 21 CFR 820 regulations, customer requirements, and local/international regulations.

Responsibilities

• Develop, implement, and manage an effective quality management system supporting the company-wide quality policy, ISO 9000, ISO 13485, and FDA 21 CFR 820 regulations for medical devices, with continuous improvement programs.
• Lead, develop, implement, and maintain quality systems for controlling product quality using process capability, inspection, auditing, and statistical analysis.
• Establish and maintain an effective quality system for preventing nonconforming product and/or its recurrence using quality planning, material review, corrective action, and quality reporting.
• Oversee selection, interviewing, onboarding, and training of new hires, including developing relevant training programs for all site personnel.
• Lead, drive, and enforce quality programs in collaboration with the manufacturing team.
• Resolve customer concerns and complaints, providing feedback on quality issues.
• Analyze daily and monthly quality reports and develop tests to improve product quality.
• Manage day-to-day department activities and ensure alignment with company quality policy and objectives.
• Ensure products meet customer expectations (approve quality specifications) and regulatory requirements.
• Lead customer audits, ISO audits, and internal audits.
• Maintain department salaries within budget, prepare the Quality budget, and schedule expenditures.
• Monitor and report site quality performance, ensuring alignment with the Business Unit and driving continuous improvement for product quality.
• Develop and implement Quality Objectives in cooperation with the Site Quality Coordinator, aligning with business unit objectives.
• Foster a quality mindset across quality and operations teams to maintain and improve quality system requirements.
• Continually improve quality by analyzing, identifying, and eliminating root causes, reducing defects, scrap, waste, and improving outputs.
• Apply and evaluate testing and inspection methods, identifying 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 and provide a safe work environment, resolving any safety issues that arise.
• Perform other job-related duties as assigned.

Requirements

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

Qualifications

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

Skills

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