Quality Engineer Manager (Tarrytown, NY)
The Quality Engineer Manager is a key position in our Quality Department supporting the quality compliance requirements of our medical devices. This individual supports existing products and new product introductions by providing and applying quality technical and current good manufacturing practices (cGMP) expertise primarily for medical devices per 21 CFR 820 and ISO 13485 and the medical device single audit program (MDSAP); OTC drug products per 21 CFR 210/211 with opportunities to extend expertise to dietary supplements and cosmetics. The individual ensures GMP compliance of third-party contract manufacturers (contractors) by developing and executing Prestige Brands’ quality assurance programs. The individual must develop and maintain effective working relationship with QA personnel at contractors, auditors, and internal stakeholders such as Regulatory Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics.
- Achieves QA operational objectives by taking on the role as the point of contact for Quality matters for assigned brands and/or contractors with a focus on medical devices.
- Determines QA strategy for assigned brands by studying product requirements, analyzing options for product stability and process validation/qualification, design control, design history file etc., recommending, preparing, and presenting corrective action plans, contributing information and opinion to cross-functional teams, preparing implementation plans and timelines.
- Supports new product introductions from an operational perspective. Reviews and approves documentation associated with the introduction or transfer of a new or existing product to contractor. These include but are not limited to design master records, design history files (DHFs), design control, stability protocols, laboratory test methods, product specifications, method validations, IQ/OQ/PQ protocols and reports. Provides support to Regulatory counterpart to ensure product dossiers are maintained and current.
- Has knowledge and expertise with design control process for medical devices.
- Evaluates the effectiveness of contractors’ quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contractor response adequacy and timeliness, determining system improvements. Escalates all serious cGMP and regulatory compliance issues to department leadership. Coaches contractors where quality systems are deficient; drives remedial action where necessary.
- Defines the quality obligations and responsibilities of contractors by preparing, negotiating, and reviewing quality agreements.
- Assures the quality of commercial product by reviewing and approving contractors’ change controls, deviations, nonconformances, and out of specification investigations. Initiates and conducts internal change controls, planned deviations, and investigations where applicable.
- Prepares reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as stability, complaints, nonconformance reports, deviations, investigations, CAPA for annual product reviews.
- Protects organization's competitiveness by keeping information confidential.
- Maintains professional and technical knowledge by tracking national and international regulatory/governmental developments; attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
- Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
- BS in a scientific discipline.
- 7 years as a Quality Engineer in medical devices (ISO13485, ISO9001 preferred) or combination with Quality Assurance experience in pharmaceutical industry (OTC) with a thorough knowledge of medical devices, Quality Systems, Quality Assurance, and Quality Control in a cGMP environment.
- Experienced in conducting and managing cGMP audits
- Demonstrated sound decision-making process and scientific problem-solving capabilities based on facts, data, and the application of risk management principles
- Ability to multitask and manage projects simultaneously
- Ability to effectively communicate and work as a team member with multiple departments, and build relationships with internal and external suppliers and customers
- Ability to work independently with little oversight
- Ability to analyze information
- Outstanding verbal and written communication skills and demonstrated interpersonal skills
- High proficiency in computer skills, i.e. Microsoft Office
- Additional certification such as CQE, CQA a plus.
Prestige is an Equal Opportunity Employer
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