Quality Manager

About the role

Manage, promote, and maintain a compliant quality management system by effectively managing 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 such as ISO 9001 & 13485 standards, FDA 21 CFR 820 regulations, customer requirements, and comply with necessary local and international regulations.

Essential Job Functions and 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.
• 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.
• Select, interview, and onboard new hires and develop a relevant training program and plan for all site personnel.
• Lead, drive, and enforce quality programs in collaboration with the 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.
• Manage day-to-day department activities.
• Support company quality policy and objectives.
• Ensure products meet 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 expenditures).
• Report 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, improve, and maintain quality system requirements.
• Continually improve quality through analyzing, identifying, and eliminating root causes.
• 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.

Core Competencies

• 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
• 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.
• Mechanical or manufacturing experience in injection molding plastics industry (or equivalent industry) is a plus.