What are the responsibilities and job description for the Quality Engineer - Sr. Manager, Device Development position at SHL Group?
Quality Engineer - Sr. Manager, Device Development
Deerfield Beach, United States of America
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.
Job Overview
Interested in this role You can find all the relevant information in the description below.
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. Projects that are Design Control specific 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
- This role will 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 effective 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 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.
Skills and Qualification
We Offer
Please note that SHL is a drug free employer. This offer of employment is contingent upon your successful completion of various preemployment screenings, including, but not limited to, a drug test, employment verification, reference checks, and a criminal background check.
We like to keep things simple and efficient. Once you’ve applied, it may take up to three weeks to review your application and get the first call with a recruiter.
Our recruitment process is focused on allowing you to show your personality, experience and competencies while giving you a great sense of who we are.
Grounded in belonging, we strive for excellence
With almost 6,000 employees of 77 different nationalities, we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth. Together, we invest in our future to maintain our leadership position in self-injection solutions.
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