System One
Director of Product Quality (Automated Manufacturing)
System One, Denver, Colorado, United States, 80285
Title:
Director of Product Quality (Automated Manufacturing)Location:
Littleton, CoType:
Direct/PermanentSalary Range:
$177,400.00 to $221,700.00 + 30% bonus and LTIsStart date:
Immediate
Are you a seasoned quality leader with experience in high-volume, highly automated manufacturing environments? Do you thrive in dynamic settings and possess the strategic mindset to drive quality improvements for new product lines? If so, we invite you to apply to our client, a global medical device company, renowned for its innovative products, as the Director of Quality.
In this pivotal role, you will lead all quality-related teams and activities, driving product quality improvement efforts while serving as a key member of the factory leadership team. Your calm yet assertive demeanor will be crucial as you navigate and resolve potential issues, ensuring our processes meet the highest standards.
Responsibilities:Lead Factory Ramp Up and Efficient Production Processes:
Supports factory ramp by filling critical headcount with experienced and talented team members.Leads site validation activities related to initiating new lines and process improvements.Directs supplier quality and receiving quality assurance resources and processes to ensure tooling/equipment validations support factory production volume commitments and that nonconformance's are addressed promptly without impact to material supply.Drives clarity on product specification by partnering with R&D to ensure product and material specifications meet customer needs, and support manufacturability.Identifies the gaps and strengthens QMS where needed, including identifying procedures and policies that put product supply at risk and revamping to ensure high quality and product supply requirements are met.Partners effectively with site operational excellence leader to develop daily metrics and operating mechanisms to drive continuous improvement of NC/CAPA processes, validation, defect frequency, and other critical to quality and supply metrics.
Drives Improvements to Product Quality:
Maintains strong GEMBA orientation and drives culture of accountability and continuous improvement mindset.Understands customer issues and works to resolve problems with product, procedures and policies, driving significant change to process or system where necessary to resolve these issues.Interfaces with site and global teams to support product complaint investigations and actions, NCs or CAPAs to ensure product conformity as well as support global changes to drive down complaints.Ensures adequate root-cause investigation and resolution of issues to avoid repeat or inadequate resolution of product quality issues.
Facilitation and Relations:
Develops/maintains constructive relationships with customers, operations, and other business/regional/functional entities served and ensure such relationships exist throughout the organization.Simplify problems and develop solutions that eliminate issues and improve relationships across all functions.Works with internal and/or external resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of operations or quality group on projects or management teams.Works with global and external resources to manage all areas of responsibilities including Operations, R&D, etc.
QMS Compliance:
Demonstrates knowledge and skills of QMS/cGMP requirements including medical device and combination products.Implements QMS to support certification by regulatory bodies.Develops and reports and improves on metrics related to QMS.Ensures audit and inspection readiness at all times.Responsibilities include influencing and driving teams in the areas of process improvements, trend monitoring and correlating leading quality metrics, problem solving approaches, and data analysis. Leads root cause analysis of complex systems issues.Evaluates changes to products ensuring that the implications of changes are fully understood.Leads Management Review for factory that drives active cross-functional involvement and continuous improvement.Constantly analyzes changing business and customer needs and propose organizational or systems changes to address these needs. Recommends changes to other areas that will improve overall effectiveness.
Process and Systems:
Responsibilities include factory complaint investigation processes, internal audit processes, and CAPA processes. Works with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to high complexity. Interprets, executes and recommends modifications to operating policies where appropriate.Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role as Management Representative with Executive Responsibility.
People Management and Team Development:
Leads a culture that reflects the organizations Core Values and quality principles. Accountable for continuous development of associates toward expectations.Ensures effective formal training and development of professional skills and behaviors for associates.Promotes associates development through participation on cross-functional teams.Directs the development and management of budget for areas of responsibility.Recruits, selects, trains, appraises performance, and administers salaries of reporting employees; determines assignments and changes employees’ status.
Business Processes:
Ensures that activities are managed per the organizations Code of Conduct and appropriate business controls.Understands business process issues and priorities, and manages resources effectively to resolve problems in the processes, procedures and policies, driving change (systems, tools, training processes, and procedures) where necessary to meet customer and business needs.Influences short and long-term business goals and operating policy. Exerts influence on corporate objectives and long-range goals in areas related to QMS and compliance.
Requirements:Bachelors degree in Quality or STEM-related discipline with 10+ years experience, and 5 years management experience, or a Masters Degree in a related discipline.10 years experience and 5 years management experience, or an equivalent combination of education and experience.5+ years experience in a manufacturing environment with highly/fully automated manufacturing processes, preferably in the medical device industry.Demonstrated QMS and audit expertise for Medical Device and Combination products and knowledge of applicable standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).Extensive knowledge of U.S. and international medical device regulations and standards.Requires understanding of quality management requirements and experience in developing quality goals and measures and directing others, including R&D, suppliers, and process engineering.Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds.
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Director of Product Quality (Automated Manufacturing)Location:
Littleton, CoType:
Direct/PermanentSalary Range:
$177,400.00 to $221,700.00 + 30% bonus and LTIsStart date:
Immediate
Are you a seasoned quality leader with experience in high-volume, highly automated manufacturing environments? Do you thrive in dynamic settings and possess the strategic mindset to drive quality improvements for new product lines? If so, we invite you to apply to our client, a global medical device company, renowned for its innovative products, as the Director of Quality.
In this pivotal role, you will lead all quality-related teams and activities, driving product quality improvement efforts while serving as a key member of the factory leadership team. Your calm yet assertive demeanor will be crucial as you navigate and resolve potential issues, ensuring our processes meet the highest standards.
Responsibilities:Lead Factory Ramp Up and Efficient Production Processes:
Supports factory ramp by filling critical headcount with experienced and talented team members.Leads site validation activities related to initiating new lines and process improvements.Directs supplier quality and receiving quality assurance resources and processes to ensure tooling/equipment validations support factory production volume commitments and that nonconformance's are addressed promptly without impact to material supply.Drives clarity on product specification by partnering with R&D to ensure product and material specifications meet customer needs, and support manufacturability.Identifies the gaps and strengthens QMS where needed, including identifying procedures and policies that put product supply at risk and revamping to ensure high quality and product supply requirements are met.Partners effectively with site operational excellence leader to develop daily metrics and operating mechanisms to drive continuous improvement of NC/CAPA processes, validation, defect frequency, and other critical to quality and supply metrics.
Drives Improvements to Product Quality:
Maintains strong GEMBA orientation and drives culture of accountability and continuous improvement mindset.Understands customer issues and works to resolve problems with product, procedures and policies, driving significant change to process or system where necessary to resolve these issues.Interfaces with site and global teams to support product complaint investigations and actions, NCs or CAPAs to ensure product conformity as well as support global changes to drive down complaints.Ensures adequate root-cause investigation and resolution of issues to avoid repeat or inadequate resolution of product quality issues.
Facilitation and Relations:
Develops/maintains constructive relationships with customers, operations, and other business/regional/functional entities served and ensure such relationships exist throughout the organization.Simplify problems and develop solutions that eliminate issues and improve relationships across all functions.Works with internal and/or external resources to resolve problems of exceptional complexity and sensitivity. May be primary representative of operations or quality group on projects or management teams.Works with global and external resources to manage all areas of responsibilities including Operations, R&D, etc.
QMS Compliance:
Demonstrates knowledge and skills of QMS/cGMP requirements including medical device and combination products.Implements QMS to support certification by regulatory bodies.Develops and reports and improves on metrics related to QMS.Ensures audit and inspection readiness at all times.Responsibilities include influencing and driving teams in the areas of process improvements, trend monitoring and correlating leading quality metrics, problem solving approaches, and data analysis. Leads root cause analysis of complex systems issues.Evaluates changes to products ensuring that the implications of changes are fully understood.Leads Management Review for factory that drives active cross-functional involvement and continuous improvement.Constantly analyzes changing business and customer needs and propose organizational or systems changes to address these needs. Recommends changes to other areas that will improve overall effectiveness.
Process and Systems:
Responsibilities include factory complaint investigation processes, internal audit processes, and CAPA processes. Works with manufacturing, engineering, and other functional groups on regulatory compliance issues. Develops or participates in the development of solutions to problems of moderate to high complexity. Interprets, executes and recommends modifications to operating policies where appropriate.Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role as Management Representative with Executive Responsibility.
People Management and Team Development:
Leads a culture that reflects the organizations Core Values and quality principles. Accountable for continuous development of associates toward expectations.Ensures effective formal training and development of professional skills and behaviors for associates.Promotes associates development through participation on cross-functional teams.Directs the development and management of budget for areas of responsibility.Recruits, selects, trains, appraises performance, and administers salaries of reporting employees; determines assignments and changes employees’ status.
Business Processes:
Ensures that activities are managed per the organizations Code of Conduct and appropriate business controls.Understands business process issues and priorities, and manages resources effectively to resolve problems in the processes, procedures and policies, driving change (systems, tools, training processes, and procedures) where necessary to meet customer and business needs.Influences short and long-term business goals and operating policy. Exerts influence on corporate objectives and long-range goals in areas related to QMS and compliance.
Requirements:Bachelors degree in Quality or STEM-related discipline with 10+ years experience, and 5 years management experience, or a Masters Degree in a related discipline.10 years experience and 5 years management experience, or an equivalent combination of education and experience.5+ years experience in a manufacturing environment with highly/fully automated manufacturing processes, preferably in the medical device industry.Demonstrated QMS and audit expertise for Medical Device and Combination products and knowledge of applicable standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations).Extensive knowledge of U.S. and international medical device regulations and standards.Requires understanding of quality management requirements and experience in developing quality goals and measures and directing others, including R&D, suppliers, and process engineering.Typical Office Environment requirements include: reading, speaking, hearing, close vision, traverse, bending, sitting, and occasional lifting up to 20 pounds.
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