Sr. Quality Manager-Device & Packaging
Company: Rangam Consultants Inc.
Location: New Brunswick
Posted on: September 17, 2023
Sr. Quality Manager--Device & PackagingPURPOSE AND SCOPE OF
- Responsible for providing technical quality and compliance
oversight for commercial combination products and support to Device
Development and Manufacturing Science & Technology (MS&T).This
position is an individual contributor role, providing
customer-focused, cross-functional support to the following:
- Commercial combination products, including auto-injectors.
- Device Development, New Product Development teams that design
and develop devices and combination products for global
- MS&T Packaging Engineering functions that design, qualify
and commercialize combination product packaging, MS&T Packaging
and Network sites to ensure appropriate investigations, studies and
risk assessments are conducted.
- Assure all assigned activities are in compliance with CLIENT
Design Control Procedures and the Quality System Regulation
- Ensure risk management is executed through Risk Management
Plans, Hazard analyses, and risk analyses, eg. dFMEA, pFMEA, uFMEA
- Determines disposition of products according to CLIENT and
regulatory specifications and standards
- Reviews Annual Product Quality Reviews (APQRs) authored by
Contract Manufacturers /Packagers and supplement APQR as
- Investigate and/or evaluate manufacturing, packaging and
laboratory deviations or incidents and associated Corrective
Actions and/or Preventive Actions (CAPAs). Provide direction and
recommendations as to future course(s) of action
- Supports investigations and serves as technical quality SME for
quality events related to device combination product
- Support evaluation of changes (component, product, process)
prior to and post design transfer for impact on manufacturing
process, documentation and design control elements
- Authors and reviews Device/Combination Product Quality
- Approve product quality complaint investigations
- Review and approve validation/qualification protocols and
reports from the External Manufacturer
- Serve on Fact Finding Investigation Review Meetings
- Supports product recalls and executes plan as assigned
- Represent Quality on cross-functional teams within the "Virtual
Manufacturing Plant", Technical Transfer teams, Supplier Selection,
Serialization, Manufacturing, Packaging launch teams
- Remain current with the changing landscape of regulations in
the global device & combination product space as it relates to
Health Authority regulations and requirementsREQUIRED
COMPETENCIES:Knowledge, Skills, and Abilities
- + Strong understanding of the regulatory and compliance
requirements for design controls and risk management (21 CFR Part
11, 211, 820, ISO 13485, ISO 14971, ICH Q9, EU MDR, IVDR).
- + Proven knowledge in the use and implementation of device
standards (ISO 11040, ISO 11608) and packaging standards (ISTA 3A,
7D, ASTM D4169).
- + Experience/knowledge of device and packaging design,
statistics and design of experiments.
- + Awareness of pharmaceutical and biologic regulations and
standards including 21 CFR Part 210, 211, 600, and relevant ICH
- + Experience in implementing RFID and UDI packaging solutions
and corresponding regulatory requirements for technologies to track
and identify product.
- + Proven experience in CAPA investigation to provide solutions
for commercial operations, manufacturing and distribution
- + Experience in implementing cold chain solutions from
production, packing, storage, global transportation, local storage,
warehousing and transportation to point of sale/use.DUTIES AND
- + Provide global quality support and oversight across the
CLIENT network with respect to device, combination product
packaging/labeling and pharmaceutical primary containers, including
design, development, commercialization and post-commercialization
- + Review and approve packaging design, development and
commercialization documentation in accordance with applicable
- + Assist or perform risk assessments and analyses.
- + Assist or perform investigations and serve as technical
quality SME for quality events related to the development,
manufacture, storage, transport and/or distribution of CLIENT
products as it relates to products and packaging.
- + Review and approves change control proposals, deviations,
investigations and CAPAs as part of general quality support.
- + Serve as quality SME for products that require thermal
protection systems and monitoring.
- + Ensure compliance to cGMPs, GDPs, QSRs and applicable CLIENT
policies and standards.
- + Support inspection readiness at all CLIENT network device and
packaging operations.EDUCATION AND EXPERIENCE
- B.S. in an Engineering discipline;
- an advanced degree preferred;
- quality engineering or six-sigma certification preferred.
- Minimum of 8 - 10 years relevant work experience, specifically
in the regulated healthcare space (pharmaceuticals, biologics, or
Rangam Consultants is a minority, women-owned, disability workforce
solutions global organization. Specialized in attracting and
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Keywords: Rangam Consultants Inc., New Brunswick , Sr. Quality Manager-Device & Packaging, Executive , New Brunswick, New Jersey
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