System One
Associate Director, Engineering Quality Assurance
System One, Allentown, Pennsylvania, United States, 18103
Title: Associate Director, Engineering Quality Assurance
Location: Allentown, Pa
Schedule: M-F 8am-5 pm (on-site)
Type: Direct/Permanent
Salary Range: 150,000-160,000 + 15% bonus and full relocation package if needed
Start date: Immediate
Are you a strategic leader with a passion for driving quality excellence? This Associate Director role offers the chance to make a significant impact by overseeing two essential teams within a GMP-regulated medical device manufacturing environment. As the only Associate Director in a high-visibility position, you’ll be the trusted delegate for management and leadership, guiding a junior Quality Engineering team focused on sustaining CAPAs and investigating customer complaints. You’ll also lead an onsite Customer Complaint team that collaborates directly with manufacturing, ensuring the quality of returned units and supporting continuous improvements.
In this role, you’ll leverage your expertise in quality metrics, CAPA processes, and risk management to identify and resolve quality issues proactively. Your leadership will shape a culture of quality and innovation as you mentor and grow team members, empowering them to reach new heights. This is a unique opportunity for a driven, detail-oriented leader with a strong foundation in GMP and medical device regulations.
Responsibilities:
Leads the site Quality Engineering team and the site Customer Complaint team within GMP manufacturing of medical devices.
Oversee the management of customer complaints ensuring that they are investigated, analyzed, and resolved in a timely manner, as well as CAPAs to address root cause and prevent recurrence of quality issues.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Conduct or participate in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes.
Manage and lead a team of quality engineers and technicians, providing guidance, training, and support to ensure their professional development and performance.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
Monitor and analyze quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization.
Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
Establish and maintain quality control procedures, including inspection/control plans, testing protocols, and documentation requirements.
Develop and validate test methods while applying metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices, conduct measurement system error studies such as Gage R&R.
Apply the concepts of producer and consumer risk, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc., interpret and select variable, attribute, and zero-defect sampling plans.
Keep up-to-date with industry trends, regulatory changes, and best practices in quality engineering for medical devices, and implementing necessary updates to the quality management system
Requirements:
Background in GMP Quality and/or Medical Device Manufacturing
ASQ Certified Quality Engineering (CQE) or similar ASQ certification
Six Sigma green belt or problem-solving training (DMAIC) preferred.
Expertise with Basic statistical tools, i.e., Minitab, average, standard deviation, process capability to detect post market trends.
Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet.
Effective communication skills required.
Strong mechanical aptitude and methodical problem-solving.
Solid understanding of root cause analysis and different quality tools used to solve problems.
Risk Based Thinking and expertise in post market risk management (identification, analysis, evaluation, and treatment).
Mechanical aptitude skills for device building and/or test set-ups.
Knowledge of statistical tools and their targeted application to medical device (or combination products) post market surveillance.
Demonstration of self-motivation and leadership skills.
Knowledge of Biohazardous Materials and related safeguards and protocols.
Strong attention to detail and ability to work in a fast-paced environment.
Demonstrated ability to collaborate effectively with cross-functional team members.
Consistently demonstrates and upholds the culture and values of the organization internally and externally.
Organizational skills as well as time management skills essential for project work and coordinating activities within and across departments.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Location: Allentown, Pa
Schedule: M-F 8am-5 pm (on-site)
Type: Direct/Permanent
Salary Range: 150,000-160,000 + 15% bonus and full relocation package if needed
Start date: Immediate
Are you a strategic leader with a passion for driving quality excellence? This Associate Director role offers the chance to make a significant impact by overseeing two essential teams within a GMP-regulated medical device manufacturing environment. As the only Associate Director in a high-visibility position, you’ll be the trusted delegate for management and leadership, guiding a junior Quality Engineering team focused on sustaining CAPAs and investigating customer complaints. You’ll also lead an onsite Customer Complaint team that collaborates directly with manufacturing, ensuring the quality of returned units and supporting continuous improvements.
In this role, you’ll leverage your expertise in quality metrics, CAPA processes, and risk management to identify and resolve quality issues proactively. Your leadership will shape a culture of quality and innovation as you mentor and grow team members, empowering them to reach new heights. This is a unique opportunity for a driven, detail-oriented leader with a strong foundation in GMP and medical device regulations.
Responsibilities:
Leads the site Quality Engineering team and the site Customer Complaint team within GMP manufacturing of medical devices.
Oversee the management of customer complaints ensuring that they are investigated, analyzed, and resolved in a timely manner, as well as CAPAs to address root cause and prevent recurrence of quality issues.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
Conduct or participate in risk management activities and implementing risk management strategies to identify and mitigate potential quality issues for new and existing products and processes.
Manage and lead a team of quality engineers and technicians, providing guidance, training, and support to ensure their professional development and performance.
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring.
Monitor and analyze quality metrics and performance indicators to identify trends, areas for improvement, and opportunities for process optimization.
Uses appropriate statistical tools such as collecting and summarizing data, drawing conclusions with confidence, determining sample sizes, applying Statistical Process Controls (SPC), identifying relationships between variables, and statistical decision making.
Establish and maintain quality control procedures, including inspection/control plans, testing protocols, and documentation requirements.
Develop and validate test methods while applying metrology techniques such as calibration systems, traceability, measurement error, and control of standards and devices, conduct measurement system error studies such as Gage R&R.
Apply the concepts of producer and consumer risk, including operating characteristic curves, AQL, LTPD, AOQ, AOQL, etc., interpret and select variable, attribute, and zero-defect sampling plans.
Keep up-to-date with industry trends, regulatory changes, and best practices in quality engineering for medical devices, and implementing necessary updates to the quality management system
Requirements:
Background in GMP Quality and/or Medical Device Manufacturing
ASQ Certified Quality Engineering (CQE) or similar ASQ certification
Six Sigma green belt or problem-solving training (DMAIC) preferred.
Expertise with Basic statistical tools, i.e., Minitab, average, standard deviation, process capability to detect post market trends.
Proficient computer skills and demonstrated competence to include word-processing, database applications, and spreadsheet.
Effective communication skills required.
Strong mechanical aptitude and methodical problem-solving.
Solid understanding of root cause analysis and different quality tools used to solve problems.
Risk Based Thinking and expertise in post market risk management (identification, analysis, evaluation, and treatment).
Mechanical aptitude skills for device building and/or test set-ups.
Knowledge of statistical tools and their targeted application to medical device (or combination products) post market surveillance.
Demonstration of self-motivation and leadership skills.
Knowledge of Biohazardous Materials and related safeguards and protocols.
Strong attention to detail and ability to work in a fast-paced environment.
Demonstrated ability to collaborate effectively with cross-functional team members.
Consistently demonstrates and upholds the culture and values of the organization internally and externally.
Organizational skills as well as time management skills essential for project work and coordinating activities within and across departments.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.