Eastridge Workforce Solutions is partnering with a manufacturer of medical products in its search for a Quality Manager. Our Westfield, PA, client is an ISO-certified designer and manufacturer of products for diagnostic, orthopedic, surgical, and other medical services. This direct hire opportunity offers competitive compensation and a benefits plan. For immediate consideration for this role, apply today.

Responsibilities

• Adheres to company’s Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
• Organizes and leads regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Coach, mentor, develop, direct, train, and evaluate the work of the quality improvement personnel.
• Develops and maintains internal/external relationships with key customers, divisions, and departments in order to strengthen and maintain business operations and growth.
• Manage customer complaint and reject process to ensure accurate root cause analysis, timely response, and the determination and implementation of corrective actions.
• Monitor site quality metrics and develop countermeasures as needed.
• Provides training in the areas of root cause tools, statistics, and quality systems.

Requirements

• BS in Engineering or applicable technical fields. Master’s degree is a plus.
• 3+ years of leading successful teams or 3+ years of supervisory experience in similar fields.
• Knowledge of the Injection molding process.
• Proficiency in the application of ISO 13485 and ISO 9001 standards.
• Six Sigma Black Belt Preferred.
• Internal Auditor Certified preferred.
• Highly skilled in Quality tools e.g. FMEA, Risk Analysis, and Root Cause analysis.
• Experience with environmental monitoring practices and testing (ex. Endotoxin, LAL, etc.) is a plus
• Advance proficiency in statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)
• Ability to read and interpret drawings
• Experience and demonstrated advanced proficiency in Process Validation (IQ, OQ, PQ, TMV)
• Proficiency in Risk Management (ISO 14975)

Benefits

• Full Medical, Dental & Vision insurance
• 401(k), effective on your 1st day
• Paid holidays
• Growth Opportunities
• Tuition Reimbursement

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

We value diverse experiences, including prior contact with the criminal legal system, and applicants with criminal histories are encouraged to apply.Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds

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