Overview
On Site
USD 150,000.00 - 180,000.00 per year
Contract - Independent
Skills
Reporting
Pharmaceutics
Process Modeling
Injection Molding
Accountability
Design Controls
Decision-making
Regulatory Compliance
Resource Planning
Process Engineering
Feasibility Study
Collaboration
Testing
Recruiting
Training
Mentorship
Forecasting
IBM Rational
Technical Support
Audio Engineering
Technical Writing
Critical Thinking
Science
Quality Assurance
System Requirements
ISO 9000
Manufacturing
GMP
Medical Devices
Product Development
Risk Management
Reliability Engineering
Leadership
Project Management
Mechanical Engineering
Biomedicine
Chemical Engineering
Life Sciences
ISO 13485
Six Sigma
Design Of Experiments
Monte Carlo Method
Analysis Of Variance
DFSS
APQP
Plant Lifecycle Management
Product Lifecycle Management
Management
SAP
Manufacturing Execution System
MES
Art
Professional Development
Privacy
Marketing
Job Details
Location: Deerfield Beach, FL
Salary: $150,000.00 USD Annually - $180,000.00 USD Annually
Description:
Quality Engineer - Sr. Manager, Device Deveopment
Location: Deerfield Beach, FL
Reporting to: US Director of Quality
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
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 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 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
Bachelor's/Master Degree in Engineering, Science, or technical field
At least 10 years' 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 and provide leadership on teams and maintain positive work environment with those teams. Understanding of team functions, leadership techniques and project management methodologies
Academic association 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
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: $150,000.00 USD Annually - $180,000.00 USD Annually
Description:
Quality Engineer - Sr. Manager, Device Deveopment
Location: Deerfield Beach, FL
Reporting to: US Director of Quality
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
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 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 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
Bachelor's/Master Degree in Engineering, Science, or technical field
At least 10 years' 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 and provide leadership on teams and maintain positive work environment with those teams. Understanding of team functions, leadership techniques and project management methodologies
Academic association 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
By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.