Our client, a large manufacturing organization is seeking an experienced engineering quality professional to join their team, located in NY/NJ area to work in the capacity of Quality Manager. The chosen candidate will possess experience in the medical device, or other FDA regulated industry. The ideal candidate will have most recently or presently have the responsibility for Validation/PPAP Packages on new customer programs, as well as ensuring compliance to applicable regulatory bodies and standards (ISO13485, 21CFR820, GMP).
*Understands statistics as applied to quality principals is needed (SPC, GR&R, MSA Studies), and preferred background using Minitab software.
* Perform technical writing skills to interface with Program Managers on a daily basis.
* Participate in new product launches and engineering studies.
* Represent the customer in order to ensure that the customer's quality expectations are clearly understood and being met.
* Support Program Management team on launch and management of medical device programs.
* APQP including completion of related documentation, including : DOE's, FMEA's, Process Flowcharts, Control Plans, Capability Studies and Gage R&R's.
* Participate in product design (R&D) meetings with Medical Customers in relationship with understanding key quality deliverables.
* Oversee the development and input of initial BOM and detailed Routing
* Oversee the initiation and/or coordination of the change control process (ECO) relating to Engineering documentation.
* Responsible for SOP and Technical Writing for New Programs
* Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
* Practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance
* Ability to Understand Statistics as related to SPC, GR&R and MSA Studies
* Participate in customer, internal and registrar quality system audits.
Best Industry ? Manufacturing
Best Department ? Engineering
Bachelor's Degree in Engineering or a related discipline is required. An Advanced Degree is a plus, but not required.
10 - 12 years of experience in product quality position, with direct experience in quality system compliance is required.
Experience in medical device/life science (GxP) industry is required.
Experience with product launches is required.
Experience leading or managing 2 or more direct reports with hire/fire responsibilities is required.
Ability to read blueprints and other technical documents is required.
Understanding of ANSI/ISO drawing standards and GD&T dimensioning is required.
Ability to use Minitab is preferred.
Knowledge of quality inspection tools and methods is required.
Familiarity with Statistical Process Control (SPC) tools and methods also preferred.
Knowledge of GMP/ISO/21 CFR 820 Quality Systems is required.
Knowledge of TQM, Six Sigma or Lean Manufacturing principles is preferred.
Knowledge or MRP or ERP software is strongly preferred.
Knowledge of progressive metal stamping and/or insert molding processes is desirable.
Strong technical writing skills are required.
Exceptional analytical and computational skills are required.
Knowledge of problem-solving tools and techniques is preferred.
Expertise and proficiency in MS Office (MS Word, MS Excel, MS PowerPoint, etc.) is required.
Strong communications skills (Verbal, written and interpersonal) are required.
US Citizens or Green Card holders only apply. No H1b visa sponsorship will be offered with this position.