Manager, Quality Assurance - AID
Company: Werfen
Location: San Diego
Posted on: January 26, 2023
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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
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