Manager Global Supplier Quality
Company: Disability Solutions
Location: Libertyville
Posted on: April 25, 2024
Job Description:
We Make Life More Rewarding and Dignified Location: Libertyville
Department: Quality Summary: Provide leadership and vision for the
deployment of a sound Quality Management System that complies with
global regulatory requirements compatible with Hollister's Mission
and Vision. Drives improvements to meet customer expectations at
the lowest cost possible. Directly oversees the Global Supplier
Quality team, including the Quality Assurance associates in
Contract Manufacturing, in addition to functional oversight of the
plant-based Supplier Quality / Incoming QA team. This role may be
based in the following locations: Libertyville, IL; Ballina,
Ireland; or Kaunas, Lithuania. Hollister Incorporated operates in a
hybrid work environment. Responsibilities:
- Develop and evaluate the quality assurance models for Global
Supplier Quality (including Contract Manufacturing) and structure
on a strategic level and adjust as needed.
- Provide direct leadership to the Global Supplier Quality team
(including the quality assurance team in the Contract Manufacturing
team). In addition, provide functional leadership to the
plant-based Supplier Quality / Incoming Quality Assurance teams to
ensure alignment between the Global team and Plant-based Supplier
Quality / Incoming Quality Assurance.
- Management Representative for the virtual Contract
Manufacturing Quality Management System.
- Develop vision and provide leadership for implementation of
quality assurance responsibilities in the global management of
direct, indirect, and purchased finished good suppliers (including
supplier selection, evaluation, approval, re-evaluation, audit, and
performance) as well as tracking of quality performance, complaints
management, supplier corrective action process, rejection, and
non-conformance reporting and improvement processes.
- Collaborate with suppliers to ensure achievement of existing
quality levels and seek methods to continually improve quality and
reduce customer complaints through the use of SCAR and CAPA
processes and by cross-functional teamwork.
- Active participation at various corporate-wide and
department-specific meetings and functions, including staff
meetings, team meetings, BU meetings, and technical / should cost
and strategy meetings, representing Supplier Quality
Assurance.
- Maintain a healthy quality system for the Contract
Manufacturing virtual plant while standardizing processes across
all facilities.
- Engage early in new product commercialization processes to
ensure good supplier/material selection in the development of new
products
- Build and reinforce a Culture of Quality in a continuous
improvement environment.
- Collaborate with the manufacturing/supplier teams to ensure the
achievement of existing quality levels of manufactured products and
seek methods to continually improve quality and reduce customer
complaints.
- Provide leadership in change management and risk assessment for
process/product changes.
- Provide input to the Global Quality Management strategic
plan.
- Provide direct leadership to the overall plant operations as a
member of the GCM leadership team.
- Develop and maintain a plan for the professional development,
coaching and performance management of all direct reports.
- Build and deliver effective communications at all levels while
displaying active listening skills.
- Prepare, periodically review, adhere to, and achieve the annual
plan goals.
- Advise and participate in IT solutions for quality system
improvements for Global Supplier Quality.
- Ensure training is provided about MDSAP good manufacturing
practices and quality standards for all associates.
- Act as key liaison with all regulatory agencies including FDA,
MDSAP, and ISO Notified Bodies.
- Direct resources for verifying and releasing finished goods
into distribution.
- Responsible for achieving competency in all identified skill
requirements outlined in the associated training profile for the
position.
- Other duties and tasks as assigned Work Experience
Requirements:
- 8-12 years overall experience is required
- BS in Physical Science, Engineering, or other related
discipline
- ASQ Certified Manager of Quality / Operational Excellence (or
equivalent experience) required
- Minimum of 5 years in an FDA Regulated industry (8+ is
preferred in increasing levels of responsibility)
- Minimum of 4 years in supervision roles
- Experience in supplier quality management, quality assurance,
plant quality processes, process validation, non-conformance
management, complaint management, design assurance, auditing, team
resource management, leading teams Specialized Skills/Technical
Knowledge:
- Supervisory experience with excellent independent judgment and
interpersonal skills
- Project management skills required.
- Strong technical writing skills and attention to detail
- Strong skills in Supplier Management (evaluation,
re-evaluation, controls, approved supplier listing)
- Quality Assurance (incoming inspection, rejection,
non-conformance processes)
- Quality Auditing (external auditing preferred) including
MDSAP
- Design Assurance (understanding of design and development
process and design controls)
- Basic knowledge of medical device sterilization
- Knowledge of 21 CFR 820, ISO 13485, ISO 14971 standards, and EU
MDR regulation
- Team leadership and cross-functional team support
- Greenbelt certification preferred with knowledge of Lean and
Six Sigma methodology
- Knowledge of SAP ERP systems is preferred
- Must be proficient in English (written & verbal)
- This role is hybrid, with a minimum of 3 days in the office
#LI-Hybrid About Hollister Incorporated Hollister Incorporated is
an independent, employee-owned company that develops, manufactures
and markets healthcare products worldwide. The company spearheads
the advancement of innovative products for ostomy care, continence
care and critical care, and also creates educational support
materials for patients and healthcare professionals. Headquartered
in Libertyville, Illinois, Hollister has manufacturing and
distribution centers on three continents and sells in nearly 80
countries. Hollister is a wholly owned subsidiary of The Firm of
John Dickinson Schneider, Inc., and is guided both by its Mission
to make life more rewarding and dignified for people who use our
products and services, as well as its Vision to grow and prosper as
an independent, employee-owned company, and in the process, to
become better human beings. Our Total Rewards package in aggregate
is above market and includes competitive pay, generous paid time
off programs, peer-to-peer recognition, health and life insurance,
wellness programs and incentives, generous retirement savings, and
a unique Benefit of Employee Share Ownership Program (BESOP).
Hollister is an EO employer - M/F/Veteran/DisabilityJob Req ID:
32828
Keywords: Disability Solutions, Berwyn , Manager Global Supplier Quality, Executive , Libertyville, Illinois
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