Senior Product Quality Engineer chez Neocoil LLC

Description

Position Summary:

Serves as a product quality subject matter expert, embedding and championing quality principles throughout the facility’s daily operations. Provides leadership across key initiatives including new product development, design transfer, supplier quality, production and service controls, sustaining activities and continuous improvement initiatives — ensuring quality is upheld from product concept through obsolescence.

Job Duties and Responsibilities:

• Interprets product related standards, customer and user needs to define robust, traceable design inputs and product requirements.
• Establishes design and development plans (DDP) for assigned projects, ensuring compliance with design control requirements; aligns with program milestones.
• Manages supplier controls, including qualification, audits, and ongoing performance monitoring and SCARs.
• Authors manufacturing risk documentation (PFMEA, control plans, process validations) to ensure efficient and effective design transfer to production.
• Ensures product labeling, IFUs, packaging, and safety documentation meet established requirements and supported by objective evidence, including appropriate use of symbols and UDI.
• Applies statistical methods (e.g., SPC, trend analysis, hypothesis testing) to monitor product and process performance, support investigations, and drive SCAR/CAPA effectiveness.
• Leads sustaining engineering/continuous improvement initiatives, including design changes.
• Ensures mechanical and electrical specifications within the DMR reflect validated design outputs and incorporate risk mitigations and quality requirements.
• Leads/supports internal and external audits (ISO 13485, MDSAP, FDA, ETL, customer).
• Executes responsibilities of the Product Quality Engineer role.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.
• All other duties, as assigned.

Requirements

Essential Skills and Experience:

• Proficient in all essential skills and experience required of the Product Quality Engineer role.
• Bachelor’s degree in engineering (electrical or mechanical) or related technical field or equivalent combination of training and experience.
• A minimum of 5-7 years of quality or regulatory experience is required. Experience in the medical device manufacturing industry is preferred.
• Proficient in understanding and interpretation of written and verbal instructions, directions, and technical information.
• Advanced computer competency in MS Office (e.g., Outlook, Word, Excel, Visio) and business specific software (e.g., ERP, eQMS), IQMS is preferred.
• Influencing people; inspires alignment and action by effectively persuading and motivating others to achieve outcomes.
• Making complex decisions; solving multifaceted problems with clarity and confidence.

Reporting to this position: No direct reports

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.