Quality Manager – Healthcare

Plastikon Healthcare is looking for a hands-on Quality Manager to upgrade and improve the Quality System through active collaboration with customers (both internal and external) to achieve quality performance goals and continuous improvement of the organization. Acts as Management Representative for Quality with authority and responsibility for ensuring quality system requirements are effectively maintained. Manages interactions with customers and regulators (if needed) concerning the quality of products, systems, and processes.

RESPONSIBILITIES:

• Formulate and maintain quality goals and coordinate with other managers.
• Maximize the product reliability while minimizing its cost.
• Provide strategic planning and management of the PLASTIKON Quality Management System (QMS), the tactical execution of all aspects of quality engineering associated with the new product development, closed loop corrective action (CLCA), internal audit and material review board (MRB) processes.
• Establish, maintain, review, and improve Quality systems/programs, policies and procedures to ensure product quality and compliance consistent with corporate objectives.
• Periodically reviews the suitability and effectiveness of the Quality System with executive management.
• Participate in and provide guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement.
• Provide leadership and assistance to manufacturing/production in the resolution of critical production quality issues.
• Select, develop, and evaluate personnel to ensure the efficient operation of the function.
• Guide Production Quality Engineering team to ensure compliance to customer specific requirements, to maximize product quality, to minimize overall costs associated with quality deficiencies and activities and to minimize customer quality complaints.
• Supervise and provide direction to Quality Engineers and other department personnel on professional, personnel issues, and provides development opportunities.
• Assist in the evaluation, reporting, and resolution of product complaints/issues reported by customers.
• Provide feedback to, and support customers with quality issue resolution.
• Support Quality data analysis and reporting of manufacturing quality performance. Provide Quality Metrics compilation and reporting.
• Work with multi-functional groups and apply global business view to develop enterprise-wide solutions.
• Exercise authority to stop Production activities if warranted based on an observation or any other information that indicates the quality of the product or process is compromised.
• Work with Engineering and manufacturing to ensure internal groups and outside suppliers meet applicable quality standards.
• Maintain current familiarity with Quality Systems, industry and customer specifications, and external standards including ISO 9000, ISO 14001, and ISO 13485.
• Work independently and exert strong leadership and decision-making skills.
• Ensure that PPAP documents and internal audits are reviewed, approved, put in place and completed in a timely manner.
• Administer the Corrective / Preventive Action (CAPA) System and Conflict Analysis and Resolution (ICAR) System.
• Ensure compliance with the document control program.
• Develop and oversee the Quality training program to ensure GMP compliance and internal training requirements. Assist in training company employees on the principles of Quality and other Quality System elements.
• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Review and analysis of internal and external quality data to detect trends and monitor product quality.
• Develop stability protocols and studies as needed for Medical Device customers.
• Provide QA review of manufacturing, quality and customer documents that are submitted to regulatory agencies as needed for Medical Device customers.
• Support interactions with regulatory agencies related to quality and compliance systems.
• Provide Quality Engineering support in resolving supplier-related quality issues.
• Specify and develop special inspection equipment, fixtures, and procedures in conjunction with manufacturing.
• Facilitate the periodic review of documents to comply with QMS requirements.
• Develop budget for Quality programs/functions and ensures adherence to the budget.

REQUIREMENTS:

• Bachelor’s degree in mechanical, manufacturing, industrial or similar engineering field. Master’s Degree preferred.
• 5+ years’ experience in a GMP (medical device or healthcare) manufacturing environment.
• 3+ years of quality assurance supervisory/managerial experience in a fast-paced manufacturing environment
• Ability to work flexible hours including weekends to support production.
• Proficient in Microsoft Office tools: Outlook, Excel, Word and PowerPoint.
• Knowledge of production/engineering of injection molded plastic, statistical process control techniques and application, and design failure analysis.
• Solid understanding of Six Sigma, Lean Manufacturing Skills, Project management, ISO standards for medical device industry and Good Manufacturing Practices (GMP).

COMPENSATION & BENEFITS:

Salary Range:

The salary range for this position is a guideline and compensation will be determined by factors such as job-related knowledge, skill level, experience, education and training, and work location.

• California: $140,000 per year – $160,000 per year

Benefits:

Full-time Plastikon employees have access to medical, dental and vision insurance, 401(k) plan with employer match, company paid Basic Life, AD&D, disability insurance, Healthcare and Dependent Care Flexible Spending Accounts (FSA), Employee Assistance Program, commuter benefits (California employees only), Paid Time Off, paid holidays, and more.