Senior Manager, Site Quality

Craftech•Ontario, CA

4d•$140,000 - $190,000

About The Position

The Senior Manager, Site Quality is responsible for managing, promoting, and continuously maintaining a compliant quality management system through oversight of the quality department and its activities, including validation, quality inspection, document control, change control, customer complaints, metrology, CAPA management, nonconforming product, calibration, receiving inspection, and product release. The role ensures that the manufacturing site meets and applies Global Quality Policies and Guidelines, ISO 9001 and ISO 13485 standards, FDA 21 CFR 820 regulations, customer requirements, and applicable local and international regulations. The position leads site quality systems and programs, supports continuous improvement, develops personnel and training, collaborates with manufacturing, and oversees customer and regulatory audits. It also manages department operations and resources, budgets, quality performance, and workplace safety.

Requirements

Expert knowledge and ability to interpret ISO 13485, ISO 9000, 21 CFR 820, and cGMP requirements.
Ability to lead and implement quality management systems applicable to ISO and 21 CFR regulations.
At least 5 years of experience leading and implementing quality systems in a pharmaceutical or medical device environment.
Demonstrated understanding of industry-standard validation tools and techniques.
Demonstrated ability with metrology and basic inspection tools, and knowledge of metrology and injection molding workmanship standards.
Ability to develop and conduct quality-related training programs.
Effective verbal and written communication skills, including excellent English communication skills.
Good organizational skills.
Exceptional leadership skills, including the 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.
Understanding and use of sampling plans, Gauge R&R, statistical techniques, and SPC.
Ability to use a personal computer and Windows-based software; Outlook, Word, and Excel are preferred.
Bachelor’s degree desirable; a four-year college degree, preferably in a science, chemical, pharmacy, plastics, or engineering field, or equivalent combined college and work experience.

Nice To Haves

Fluency in Spanish.
Knowledge of processing engineering polymers.
Six Sigma and Lean knowledge.
Experience with PC-DMIS metrology software, IQMS manufacturing software, and Minitab.
Manufacturing experience in the injection-molding plastics industry or an equivalent industry.

Responsibilities

Lead, develop, implement, and manage quality management systems that support company quality policy, ISO 9000, ISO 13485, FDA 21 CFR 820 regulations for medical devices, and continuous improvement programs.
Develop, implement, and maintain quality systems for product quality control using process capability, inspection, auditing, and statistical analysis.
Develop, implement, and maintain systems to prevent nonconforming product and recurrence through quality planning, material review, corrective action, and quality reporting.
Select, interview, and onboard new hires, and develop relevant training programs and plans for site personnel.
Lead, drive, and enforce quality programs in collaboration with the manufacturing team.
Resolve customer concerns and 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 and regulatory requirements, including approving quality specifications.
Lead customer, ISO, and internal audits.
Achieve financial objectives by maintaining department salaries within budget, preparing the quality budget, and scheduling expenditures.
Report site quality performance and ensure alignment with the Business Unit; manage continuous improvement for product quality.
Work with the Sites Quality Coordinator to develop and implement Quality Objectives aligned with Business Unit objectives.
Promote a quality mindset across quality and operations and maintain and improve quality system requirements.
Improve quality by analyzing, identifying, and eliminating root causes, including reducing defects, scrap, and waste and improving outputs.
Apply and evaluate testing and inspection methods and identify requirements for improvement.
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 work accuracy.
Ensure shift-to-shift communication.
Provide a safe work environment and resolve safety issues.
Perform other job-related duties as assigned.