Manager Quality Improvement & CAPA

Hollister Incorporated•Libertyville, IL

65d•Hybrid

About The Position

The Manager is responsible for leading, maintaining and continuously improving key elements of Hollister's Quality Management System (QMS) worldwide. The role will provide leadership, guidance and global support across all Hollister locations. This position is tasked with ownership and management of various global QMS elements such as: Corrective and Preventive Action (CAPA) process Nonconformances (Product & Process) The Manager will maintain proficiency on standards, regulations and guidance documents in order to provide continuing awareness on changing requirements and ensure compliance. This role will contribute to Hollister's mission, vision and strategic plan by leading a compliant, suitable and effective CAPA and Nonconformance programs and driving improvement initiatives aligned with best industry practices

Requirements

Number of Overall Years Necessary: 8-12
Minimum of 8 years of healthcare industry experience.
Deep understanding of USA and International regulations and standards, including FDA cGMP, EUMDR and ISO 13485
Experience working in a regulated environment, quality management systems, or related field is essential, medical devices or pharma industry experience, is highly preferred
Bachelor's Degree in scientific or engineering discipline required. Advanced Degree desired.
Industry certifications are desirable.
Problem Solving & CAPA training preferred
Certified Quality Auditor (CQA) and Certified Quality Manager (CQM) preferred
Strong problem-solving skills; ability to analyze all aspects of a situation, challenge current methods, identify potential solutions, make informed decisions and implement the best solution in an efficient, timely manner. Ability to apply and cultivate new approaches to problem solving.
Ability to execute on strategic initiatives and manage day-to-day deliverables.
Experience with ISO13485 standard and its requirements.
Experience with 21CFRpart 820, EUMDR and its requirements.
Strong oral and written communication skills.
Ability to build, work with, and strengthen relationships with team members in other departments, other sites, outside auditors and business partners; as well as extensive experience in leading and facilitating diverse teams, both face-to-face and in a virtual setting.
Demonstrated leadership and mentor skills indicating management capabilities to meet or complete project deadlines, initiatives and schedules, as well as communicating and providing direction to team members.
Demonstrated interest in, and understanding of, industry developments and trends.
Ability to travel
Verbal and written communications, reading, and typing

Responsibilities

Provides leadership for establishment, improvement and maintenance of Hollister's CAPA and Nonconformance programs.
Lead, understand, champion and implement new regulations and guidelines to ensure compliance with ISO 13485 standards, 21CFRPart820 EUMDR, and other regulations as applicable.
Manage and govern the CAPA process. Act as CAPA subject matter expert & coordinator for the Libertyville location
Provides guidance, direction and support across all sites and helps drive best practices
Conducts assessment of changing standards, regulations and guidance documents, and identifies any needed changes to internal policies, procedures, processes, or practice
Collaborates extensively across manufacturing sites and across functions including Quality, Regulatory Affairs, IT, Operations, R&D and other departments as applicable
Provides education on relevant quality systems and processes, and drives accountability across the organization
Analyzes process performance based on quality data & metrics and provides recommendations for improvement as applicable
Maintains up to date knowledge of all areas of responsibility which impact the Hollister Quality Management System.
Provides leadership for establishment, improvement and maintenance of Hollister's CAPA and Nonconformance programs
Lead, understand, champion and implement new regulations and guidelines to ensure compliance with ISO 13485 standards, 21CFRPart820 EUMDR, and other regulations as applicable.
Manage and govern the CAPA process. Act as CAPA subject matter expert & coordinator for the Libertyville location
Provides guidance, direction and support across all sites and helps drive best practices
Conducts assessment of changing standards, regulations and guidance documents, and identifies any needed changes to internal policies, procedures, processes, or practice
Collaborates extensively across manufacturing sites and across functions including Quality, Regulatory Affairs, IT, Operations, R&D and other departments as applicable
Provides education on relevant quality systems and processes, and drives accountability across the organization
Analyzes process performance based on quality data & metrics and provides recommendations for improvement as applicable
Maintains up to date knowledge of all areas of responsibility which impact the Hollister Quality Management System.