Medical assistant Jobs in Hayward, CA

Quality Manager Medical Plastics

Our client a growing company with multiple plants in the US, needs a Manager of Quality at their plant in California expanding to manufacture Medical Plastic parts and components. Excellent salary up to $130K + Bonus + Relocation Assistance + Full Benefit Package + 3 Weeks vacation.

Location: Hayward, CA

Compensation: Salary of $100K - $130K per year + Bonus (Target of 10%)

Relocation: YES - Client offers relocation assistance and payments with receipts.

Benefits: Full package for medical, dental insurance, 401K + 3 Weeks Vacation + 13 days - PTO, etc.

This is a privately held company in business for 40 years with multiple manufacturing sites.

Be part of the medical component contract manufacturing site with around 100+ employees.

The manufacturing operation is Injection molding of plastic parts & components for the medical industry.

The Quality Manager will have 2 reports. This role will report to the Executive VP of Manufacturing.

Accountable for upgrading and improving 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.

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 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.

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/manufacturing to ensure internal groups/outside suppliers meet quality standards.

Maintain current familiarity with Quality Systems, industry and customer specifications, and external standards including ISO 9000, ISO 14001, ISO 13485.

Ensure that PPAP documents and internal audits are reviewed, approved 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 all Quality System elements.

Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing 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.

Candidate Must Have:

• Bachelor's degree in mechanical, manufacturing, industrial or similar engineering field
• 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
• Knowledge of production/engineering of injection molded plastic, statistical process control - SPC techniques and application, and design failure analysis.
• Working knowledge of ISO 9000, ISO 14001, ISO 13485 regulations.
• Skills in Quality Management, Staffing, Management Proficiency, Coordination, Coaching, Developing Standards, Quality systems Improvement, Decision Making, Strategic Planning, etc.

Candidate Nice to Have:

• Masters Degree
• Certified Quality Auditor certification, or equivalent.
• Audit or inspection experience preferred.
• Startup or Small company experience working in a dynamic and hands-on role.
• Solid understanding of Six Sigma, Lean Manufacturing Skills, Project management, ISO standards for medical device industry and Good Manufacturing Practices (GMP).