Quality Engineer Senior Manager, Device Development

Job Overview

The Quality Engineering Senior Manager position is primarily responsible for overseeing Design Control and Risk Management activities that apply to product and process development lifecycles led by US Design Office.

Design Control specific projects may include New Product and Process Design / Significant Design Changes to Existing Product Business Scale-up Projects (eg, New Automation Lines, New Injection Molding Toolsets, New metal processing lines).

This position may also lead or support Quality functional initiatives (eg : PEC- Predictability, Efficiency and Compliance Projects) as well as improvement activities (eg : Continuous Improvements projects).

This position is accountable for delivering high reliability and quality products through efficient execution of Design Control governance, inculcate the culture of statistically robust, data-driven decision-making process, and meeting quality objectives / metrics for the business.

This position is also responsible for ensuring that the product and process development activities are in compliance with all applicable internal, corporate, and regulatory standards or requirements.

This position will involve staffing, developing, and resource planning for Quality Engineers for the US Design Office. Additionally, this role may serve as a Quality Core Team member on new product / process development efforts or other Projects which are linked to corporate strategic imperatives.

Main Responsibilities

• Supervisory Responsibilities : Manage a team of 2-5 Quality Engineers.
• Provide Quality Engineering / Design Assurance leadership to the team to ensure customer needs and regulatory requirements are met.

Ability to look at the larger picture of the development project and influence the Core Team to assure quality objectives are met.

• Provide Quality Engineering leadership for New Product / Process Development (NPD), Product Care (PC) and transfer to manufacturing.
• Provide Risk-Based approach to design & development leadership and support risk management activities.
• Responsible for the efective implementation of the SHL Risk Management process in the US Design Office. Implements policies, procedures, and controls to monitor and minimize risk to patient safety, to customers and to SHL Medical.
• Provide direction for quality engineering staff activities, i.e., concept selection, feasibility studies, define design inputs / outputs, collaborate with testing & simulation department in design verification activities, design validation activities and risk management activities.
• Build a strong quality engineering team by hiring qualified candidates, establishing, and actively managing performance expectations, and providing training opportunities to direct staff.

Serve as a coach / mentor for cross-functional Engineers in Design Assurance aspect.

Responsible for forecasting project QE resources and rational of headcount allocation. Recruit and hire quality staff for team in the United States.

Selects, develops and evaluates personnel to ensure the efficient operation of the function.

• Provide Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review and investigations.
• Implements all aspects of the company’s design and development process to new medical device products.
• Demonstrate a high level of technical skills; apply sound engineering judgment, technical writing skills, statistical skills, and critical thinking in product development activities and resolution of quality issues.
• Performs other related duties as assigned.

Skills and Qualification

• Bachelor’s / Master Degree in Engineering, Science, or technical field
• At least 10 years’ of work experience in Quality Engineering
• 3+ years of experience with 21CFR Part 820 and ISO 13485 and Quality system requirements in other geographies
• 3+ years of experience with relative ISO and FDA regulations and Good Manufacturing Practices (GMP)
• 3+ years of experience with medical device product development, design verification / validation, risk management, reliability engineering, and process validation
• Ability to participate, provide leadership on teams and maintain a positive work environment with those teams. Understanding of team functions, leadership techniques and project management methodologies
• Academic associations to mechanical, industrial, biomedical, chemical engineering, material / life science are highly valued.
• cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93 / 42 / EEC
• Certified Quality Engineer / Six Sigma Black Belt certification preferred.
• Advanced Statistical knowledge and Quality Tools (eg : DOE, monte-Carlo simulation, ANOVA, MSA, DFSS, APQP)
• PLM (Product Life-cycle management)
• SAP, Manufacturing Execution Systems / MES will be an advantage

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization
23 days ago