HCLTech
Polyguard
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Engineering & R&D

Senior Developer - MDR, 510(k), DHF Remediation

Orange, United States

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Job Summary

The Senior Quality Engineer Associate shall provide quality and technical leadership to ensure new and existing medical devices meet their intended use.

Key Responsibilities

1.Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
2.Ensures effective risk management or product harms and hazards and improves capability of processes.
3.Leads development team in design control strategy and implementation
4.Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
5.Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
6.Quality Management Systems support including Design Control, Risk Management and Change Control, 
7.Perform problem solving and identify Non-Conformance, Corrective and preventive Actions (NC/CAPA).

Skill Requirements

1.Bachelors or equivalent degree in Engineering or other related technical field is required.
2.Minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required
3.Practical understanding of QSR/ISO medical device regulations especially in design controls, and risk management.
4.Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices
5.Thorough knowledge of leading-edge Quality Engineering, design control, verification and validation (V&V) tools and methodologies.
6.Ability to function in a team environment with strong  communication and interpersonal skills.
7.Proficieny in Microsoft Suite tools (Word, Excel, PowerPoint, VISIO, Power BI)

Other Requirements

1.Experience in Medical Device industry.
2.American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
3.Ability to develop and implement Quality standards.
4.Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable
5.Up to 10% domestic travel

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