Manager, Quality Assurance - AID

Company: Werfen
Location: San Diego
Posted on: January 26, 2023

Job Description:

Overview
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. - Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. -Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Job SummaryWerfen Autoimmunity Quality Assurance (QA) Manager provides leadership and guidance in maintaining quality system effectiveness while driving continuous improvement in product and quality systems. This position works closely and collaboratively with the other functional areas. The QA Manager is responsible for overseeing the activities of their assigned team(s) and individually performing tasks to ensure the effectiveness of the Quality Systems. This position manages work assignments and processes to meet productivity standards, quality goals and department objectives. Responsible for providing support to staff, resolving operational and performance issues, and implementing improve-ments to operations, processes and the work environment. Trains and onboards new staff, assesses performance of direct reports and provides development opportunities. Ensures business goals, deadlines and performance standards are met. Communicates and collaborates with staff, department leadership, and other Autoimmunity functions to meet goals and produce the highest quality products and services. Ensures staff comply with company policies and expectations. All activities are per-formed in accordance with standard operating procedures, Quality System, safety, and administrative regulations.
Responsibilities
Key Accountabilities
--- Department Management - - -o Manage personnel including recruitment, interviewing, selection, training, coaching, de-velopment, coordination of assignments and workload priorities, goal setting, termina-tion, and performance management. - - -o Educate and broaden the quality knowledge within the teams; develop and deploy per-sonnel skill assessment and training plans. - - -o Ensure regular and meaningful communication throughout team, and with department management, through effective use of one-on-one meetings, team meetings and oth-er forms of formal and informal communication. - - -o Proactively manages employee relations issues; uses judgement in consulting with de-partment leadership and Human Resources. - - -o Author, implement, and ensure maintenance of departmental procedures, work in-structions, and templates associated with the quality assurance activities. - - -o Prepare reports to management on the performance of the quality system, including management-requested reports and management review meetings minutes. - - -o Assist in the development of department budget and monitors department expendi-tures.
--- Continuous Improvement - - -o Trend, analyze and identify continuous improvement opportunities and coordi-nate/perform actions to improve processes and metrics; proactively manage critical quality issues. - - -o Contribute, manage, and execute proactive quality strategies and plans. - - -o Creates and maintains productive relationships with other departments and promotes collaboration within Autoimmunity and other Werfen manufacturers and Affiliates. - - -o Ensure that risks to quality systems are identified and mitigated through effective con-trols. - - -o Influence and drive cross-functional projects for quality improvement - - -o Recommend quality objectives then ensure they are monitored and achieved. -
- - -o Ensuring QMS effectiveness through audits, data analysis, and projects to achieve com-pany and department objectives.
--- Audits - - -o Set and oversee the annual schedule of internal quality and external audits. - - -o Host and guide quality audits. - - -o Communicate progress and drive timely corrective actions from both internal and ex-ternal audit findings. - - -o Respond to client and other external regulatory agencies to provide supporting infor-mation as needed
--- Quality Assurance Activities - - -o Facilitate effectiveness of quality management system activities for corrective and pre-ventive actions, internal & external audits, document & records management, compli-ance administration, stop shipment management, change - - - - -management, product re-lease, quality system training, management review, supplier management, quality im-provements, quality monitoring and reporting, and nonconformance/deviations man-agement. - - -o Ensure the conduct of timely investigations for quality events, such as nonconformanc-es, deviations, and audit findings. - - -o Ensure the meticulous review and approval of product quality and quality systems doc-umentation. - - -o Develop systems to track, trend, report and reduce nonconforming situations. Identify all batch nonconformance and initiate appropriate actions for those nonconformances - - -o Provide advice within the organization on the best tactical direction issue to maintain Quality Management System effectiveness in alignment with company mission, values, and business goals. --- - - -o Actively engage with other department functions to ensure that QMS and quality im-provements are well supported to achieve expectations; maintain effective and profes-sional communication between all parties. - - -o Make informed data-driven quality decisions without oversight. - - -o Acquire and maintain current knowledge of regulatory compliance and industry practic-es through reviews of publications, conferences, and publicly available information to properly adjust compliance activities and approaches. - - -o Facilitate a quality culture and promote collaboration, quality requirements understand-ing and continuous improvement. - - -o Detailed review and approval of quality documentation.
--- Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
--- Represents the AID management team and reflects the values of Werfen and Inova as a role model to employees, suppliers, and customers.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Networking/Key relationships--- Manufacturing teams--- Regulatory teams--- R&D teams including Manufacturing Technical Support--- Contract manufacturers--- Quality Assurance--- Quality Control--- Product Complaint Group--- Suppliers
--- Senior and Executive Management--- Affiliates--- Other Werfen Affiliate and Manufacturer's functions
Qualifications
Minimum Knowledge & Experience required for the position:
Education:--- Bachelor's degree in biology, biochemistry, life science, engineering, or equivalent required. Advanced degree preferred.--- Certified Medical Device Auditor (preferred)
Experience:--- A minimum of 6 years of progressive quality experience in in-vitro diagnostics and/or medical device industry. --- At least 5 years of experience managing or leading a team required, preferably in a regu-lated manufacturing environment. --- At least 3 years of successful auditing and inspection experience including managing the preparation for and hosting of Regulatory Inspection including successfully resolving issued nonconformance/violations e.g., 483s. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:--- Advanced knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, or other regulations and standards).--- Advanced knowledge of quality principles including risk management industry practices, and standards with demonstrated application.--- Advanced knowledge and ability to apply Lean Principles in the organization to re-engineering and maintain scalable processes.--- Advanced ability to interpret and apply compliance and quality systems requirements.--- Advanced ability to organize and complete multiple tasks in a fast-paced environment as a team member and/or as an individual contributor in a timely, accurate manner under general supervision.--- Advanced ability to lead, collaborate and influence cross-functional teams to achieve common goal, with and without direct authority.--- Advanced ability to effectively manage multiple concurrent assignments and proactively independently identify, assess risk for, and develop proactive and creative approaches to barriers to success.--- Advanced ability to constructively resolve conflict resolution.--- Advanced ability to in critical thinking capability and decision making. --- Advanced ability to function effectively with ambiguity in a rapidly changing environment.--- Advanced ability in influencing and negotiation while building collaborative relationships and maintaining strong, positive working relationships.--- Advanced ability to independently identify, assess risk for, and mitigate.--- Advanced ability to be self-motivated, proactive, accountable hands-on, and flexible--- Working ability in constructive conflict resolution.--- Working ability to apply sound, systematic problem-solving methodologies and root cause investigation to identify, prioritize, communicate, and resolve quality issues--- Working ability delivering effective presentations and training material.--- Advanced skills in verbal and written communication including presenting.--- Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.--- Working interpersonal and emotional intelligence skills to develop and lead a high performing team.--- Working data-driven, analytical skills.
Travel requirements:No routine travel requirements.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise -our Werfen team.
www.werfen.com

Keywords: Werfen, San Diego , Manager, Quality Assurance - AID, Executive , San Diego, California