Manager, Quality System Complaints (Onsite Clinton, PA))

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

The Manager, Quality Complaints manages multiple Global Quality Systems functions including but not limited to: Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning; Quality Systems Metrics and Trending - Global Key Performance Indicators (KPIs).  This role manages a team of engineers, and technicians located onsite for both equipment and disposables at our state-of-the-art Clinton, PA Manufacturing facility. Clinton, PA is located in the Metropolitan Pittsburgh area and just North of Upper West Virgina.

What You Will Do:

• Effectively manage the deployment of business strategies, the utilization of personnel, and the scope and timeliness of responses.  Build strategic relationships to further Quality organizational objectives and collaborates with all levels in executing quality objectives.

• Works to achieve the overall objectives of the company and ensures that quality strategies are aligned for the areas of responsibility.

• Oversee the quality system compliance through Global Key Performance Indicators (KPIs) to monitor performance of key elements of the quality system.

• Assist management with objective evaluation of overall the Global Quality System performance and provides guidance for implementation of improvements, corrective and preventive actions for related quality processes.

• Work with management to ensure the effective implementation and maintenance of Quality System requirements and procedures, to domestic and international regulations and standards.

• Execute on the Quality System strategy and facilitates implementation.

• Participate in 2nd party agreements (e.g. contract manufacturing, distribution, acquisitions, etc.) through due diligence activities of quality system assessment, contractual agreement, and quality system integration.

• Possess working knowledge of ISO13845:2016, FDA 820 CFR, MDSAP, JPAL, CMDR, MDR, & ANVISA regulations and Standards.

Experience/ Skills:

• 8+ years of engineering experience, with 2+ years in a leadership role focused on Medical Device Equipment or contract manufacturing.

• Bachelor's Degree Engineering, or Life Sciences , Masters preferred.

• Experience with cleanroom assembly and finished medical devices equipment, complaint investigation and adverse event reporting

• Strong project management capabilities with a proven track record of successful product introductions.

• Expertise in Design for Manufacturability (DFM) and process validation.

• Proficiency in quality systems and regulatory compliance (e.g., ISO 13485, FDA).

• Knowledge of tools such as CAD software, ERP systems, and Lean manufacturing principles.

• Excellent communication and interpersonal skills to engage effectively with customers and cross-functional teams.

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