The Judge Group
Sr. Mgr, Quality Engineering - Device Development (1099434)
The Judge Group, Deerfield Beach, Florida, United States, 33441
Sr. Mgr, Quality Engineering - Device Development (1099434)
Location: Deerfield Beach, FL Salary: $150,000.00 USD Annually - $180,000.00 USD Annually 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 the US Design Office. This role may lead or support Quality functional initiatives and improvement activities, and is accountable for delivering high reliability and quality products through design control governance and data-driven decision-making while ensuring compliance with applicable internal, corporate, and regulatory standards. Responsibilities
This role will manage a team of 2-5 Quality Engineers. Provide Quality Engineering/Design Assurance leadership to ensure customer needs and regulatory requirements are met, and influence project teams to meet quality objectives. Provide Quality Engineering leadership for New Product/Process Development (NPD), Product Care (PC) and transfer to manufacturing. Provide risk-based design and development leadership and support risk management activities. Responsible for the effective implementation of the SHL Risk Management process in the US Design Office; implement policies, procedures, and controls to monitor and minimize risk to patient safety and to SHL Medical. Provide direction for quality engineering staff activities, including concept selection, feasibility studies, defining design inputs/outputs, collaborating with testing & simulation in design verification, design validation, and risk management activities. Build a strong quality engineering team through hiring, performance management, and training opportunities; coach/mentor cross-functional engineers in Design Assurance. Forecast QE resources, headcount allocation, and recruit/hire quality staff for the US team; select, develop, and evaluate personnel to ensure efficient operation. Provide technical quality engineering support to resolve quality issues, including complaint review and investigations. Implement all aspects of the company's design and development process to new medical device products. Demonstrate advanced technical skills, engineering judgment, technical writing, statistical skills, and critical thinking in product development and issue resolution. Qualifications
Bachelor’s or Master’s Degree in Engineering, Science, or a technical field At least 10 years of experience in Quality Engineering 3+ years of experience with 21 CFR Part 820 and ISO 13485 and Quality system requirements in other geographies 3+ years of experience with ISO and FDA regulations and GMP 3+ years of experience with medical device product development, design verification/validation, risk management, reliability engineering, and process validation Ability to lead teams and maintain a positive work environment; understanding of leadership, team functions, and project management methodologies Academic background in mechanical, industrial, biomedical, chemical engineering, or material/science is valued cGxP Know-How including ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC Certified Quality Engineer or Six Sigma Black Belt preferred Advanced statistical knowledge and quality tools (DOE, Monte-Carlo, ANOVA, MSA, DFSS, APQP) PLM (Product Life-cycle Management) SAP, MES experience is a plus 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 Opportunities for personal and professional development within a global organization Contact: dkellogg@judge.com This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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Location: Deerfield Beach, FL Salary: $150,000.00 USD Annually - $180,000.00 USD Annually 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 the US Design Office. This role may lead or support Quality functional initiatives and improvement activities, and is accountable for delivering high reliability and quality products through design control governance and data-driven decision-making while ensuring compliance with applicable internal, corporate, and regulatory standards. Responsibilities
This role will manage a team of 2-5 Quality Engineers. Provide Quality Engineering/Design Assurance leadership to ensure customer needs and regulatory requirements are met, and influence project teams to meet quality objectives. Provide Quality Engineering leadership for New Product/Process Development (NPD), Product Care (PC) and transfer to manufacturing. Provide risk-based design and development leadership and support risk management activities. Responsible for the effective implementation of the SHL Risk Management process in the US Design Office; implement policies, procedures, and controls to monitor and minimize risk to patient safety and to SHL Medical. Provide direction for quality engineering staff activities, including concept selection, feasibility studies, defining design inputs/outputs, collaborating with testing & simulation in design verification, design validation, and risk management activities. Build a strong quality engineering team through hiring, performance management, and training opportunities; coach/mentor cross-functional engineers in Design Assurance. Forecast QE resources, headcount allocation, and recruit/hire quality staff for the US team; select, develop, and evaluate personnel to ensure efficient operation. Provide technical quality engineering support to resolve quality issues, including complaint review and investigations. Implement all aspects of the company's design and development process to new medical device products. Demonstrate advanced technical skills, engineering judgment, technical writing, statistical skills, and critical thinking in product development and issue resolution. Qualifications
Bachelor’s or Master’s Degree in Engineering, Science, or a technical field At least 10 years of experience in Quality Engineering 3+ years of experience with 21 CFR Part 820 and ISO 13485 and Quality system requirements in other geographies 3+ years of experience with ISO and FDA regulations and GMP 3+ years of experience with medical device product development, design verification/validation, risk management, reliability engineering, and process validation Ability to lead teams and maintain a positive work environment; understanding of leadership, team functions, and project management methodologies Academic background in mechanical, industrial, biomedical, chemical engineering, or material/science is valued cGxP Know-How including ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC Certified Quality Engineer or Six Sigma Black Belt preferred Advanced statistical knowledge and quality tools (DOE, Monte-Carlo, ANOVA, MSA, DFSS, APQP) PLM (Product Life-cycle Management) SAP, MES experience is a plus 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 Opportunities for personal and professional development within a global organization Contact: dkellogg@judge.com This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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