Job Number: 24851970
SENIOR QUALITY MANAGER DEVICE AND PACKAGING
NEW BRUNSWICK, NJ
-B.S. In an Engineering discipline, 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 medical devices).
The pay ranges between $99.55 - $106.13/hr W2.
- 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 medical devices).
- 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 guidelines.
- Experience in implementing RFID and UDI packaging solutions and corresponding regulatory requirements for technologies to track and identify products.
- Proven experience in CAPA investigation to provide solutions for commercial operations, manufacturing, and distribution sites.
- Experience in implementing cold chain solutions from production, packing, storage, global transportation, local storage, warehousing, and transportation to point of sale/use.
- 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 markets.
- 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 the Client's Design Control Procedures and the Quality System Regulation.
- Ensure risk management is executed through Risk Management Plans, Hazard analyses, and risk analyses, e.G., dFMEA, pFMEA, uFMEA etc.
- Determines disposition of products according to the Client's and regulatory specifications and standards.
- Reviews Annual Product Quality Reviews (APQRs) authored by Contract Manufacturers /Packagers and supplement APQR as required.
- Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective Actions and/or Preventive Actions (CAPAs).
- Provide directions 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 Agreements.
- 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 requirements.
- Provide global quality support and oversight across the Client's network with respect to device, combination product packaging/labeling and pharmaceutical primary containers, including design, development, commercialization, and post-commercialization activities.
- Review and approve packaging design, development, and commercialization documentation in accordance with applicable regulatory requirements.
- 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 the Client's 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 with cGMPs, GDPs, QSRs and applicable Client policies and standards.
- Support inspection readiness at all the Client's network device and packaging operations.
This 12+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com
ALPHA'S REQUIREMENT #23-01459
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE