Actalent
Director Of Quality Assurance
Actalent, Draper, Utah, United States, 84020
Actalent Director Of Quality Assurance Draper, Utah
The Director, Quality Assurance will manage a team to ensure smooth and continuous operations of our site quality system, quality control and assurance inspection for in process and finished goods. They will also oversee process audits and final product release documentation, advise and facilitate failure investigations, and share compliance methodologies for manufacturing of valve assemblies.Minimum Qualifications:
Bachelor's Degree in a related field *RequiredExperience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices *RequiredDemonstrated track record in people management *RequiredResponsibilities:
Manage supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.Plan and direct multiple complex quality assurance projects (e.g., CAPA) with accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross-functional groups.Negotiate solutions and reach consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas.Responsible for inspection of in-process and finished goods, assemblies, and components including proper implementation.Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives.Provide recommendations and implement workforce planning.Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing, and implementing technology solution options.Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders.Other incidental duties.Skills:
Class II Med Device, Class III Med Device, Med Device, FDA, CAPA, audit, Regulatory affairs, Quality assurance, Quality control, Root cause analysis, cGMP, lean six sigma.Additional Skills & Qualifications:
Experience working in a regulated industry, preferably the medical device or pharmaceutical industry.Experience in supporting/implementing FDA’s Case for Quality program.Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems.Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.Expert understanding of quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems.Expert knowledge of applicable quality regulations (e.g., cGMP compliance).Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business.Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment.Knowledge of Lean Manufacturing concepts and Six Sigma.Frequently interacts with internal and external management and customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications.Lead briefings and technical meetings for internal and external representatives.Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage.About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion:
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Maintaining an inclusive environment through persistent self-reflection.Building a culture of care, engagement, and recognition with clear outcomes.Ensuring growth opportunities for our people.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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The Director, Quality Assurance will manage a team to ensure smooth and continuous operations of our site quality system, quality control and assurance inspection for in process and finished goods. They will also oversee process audits and final product release documentation, advise and facilitate failure investigations, and share compliance methodologies for manufacturing of valve assemblies.Minimum Qualifications:
Bachelor's Degree in a related field *RequiredExperience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices *RequiredDemonstrated track record in people management *RequiredResponsibilities:
Manage supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.Plan and direct multiple complex quality assurance projects (e.g., CAPA) with accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross-functional groups.Negotiate solutions and reach consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas.Responsible for inspection of in-process and finished goods, assemblies, and components including proper implementation.Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives.Provide recommendations and implement workforce planning.Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing, and implementing technology solution options.Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders.Other incidental duties.Skills:
Class II Med Device, Class III Med Device, Med Device, FDA, CAPA, audit, Regulatory affairs, Quality assurance, Quality control, Root cause analysis, cGMP, lean six sigma.Additional Skills & Qualifications:
Experience working in a regulated industry, preferably the medical device or pharmaceutical industry.Experience in supporting/implementing FDA’s Case for Quality program.Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems.Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.Expert understanding of quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems.Expert knowledge of applicable quality regulations (e.g., cGMP compliance).Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business.Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment.Knowledge of Lean Manufacturing concepts and Six Sigma.Frequently interacts with internal and external management and customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications.Lead briefings and technical meetings for internal and external representatives.Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage.About Actalent:
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation, and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion:
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Maintaining an inclusive environment through persistent self-reflection.Building a culture of care, engagement, and recognition with clear outcomes.Ensuring growth opportunities for our people.The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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