Wiss
Experienced Recruiting Specialist @ Wiss
Background:
A Wiss manufacturing client located in Essex County, NJ is seeking a Validation Engineer to join their team. In this role you will be responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).
The position is FULLY ONSITE no exceptions. LOCAL CANDIDATES ONLY SHOULD APPLY! Compensation is outlined below.
Core Responsibilities:
Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
Works independently, taking lead on PPAP / Validation Completion. Leads team to provide deliverables, and takes initiative to proactively management the PPAP Process, including all applicable APQP documentation.
Responsible for SOP and Technical Writing for New Programs
Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance
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.
Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
Ability to 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.
Primary auditee responsible for Validation, PPAP, APQP Packages to third party auditors.
Ability to Understand Statistics as related to SPC, GR&R, MSA Studies
Lead-in customer, internal and registrar quality system audits.
Qualifications:
Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical device/life science (GxP) industry required.
Requires a 4-yr engineering degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
Knowledge of GMP/ISO/21 CFR 820 Quality Systems required.
Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
Knowledge of progressive metal stamping and/or insert molding processes desirable.
Target Compensation:
$100k-$120k salary (commensurate with experience) + a discretionary bonus.
Benefits:
Medical insurance
Vision insurance
401(k)
Seniority level: Mid-Senior level
Employment type: Full-time
Job function / Industries: Manufacturing and Medical Equipment Manufacturing
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A Wiss manufacturing client located in Essex County, NJ is seeking a Validation Engineer to join their team. In this role you will be responsible for Validation/PPAP Packages on new customer programs, as well as ensuring compliance is applicable regulatory bodies and standards (ISO13485, 21 CFR 820, GMP).
The position is FULLY ONSITE no exceptions. LOCAL CANDIDATES ONLY SHOULD APPLY! Compensation is outlined below.
Core Responsibilities:
Responsible for Master Validation Reports, including writing and execution of IQ, OQ, PQ Protocols
Works independently, taking lead on PPAP / Validation Completion. Leads team to provide deliverables, and takes initiative to proactively management the PPAP Process, including all applicable APQP documentation.
Responsible for SOP and Technical Writing for New Programs
Must have practical knowledge of GMP, ISO13485, and/or 21 CFR 820 Compliance
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.
Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s.
Ability to 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.
Primary auditee responsible for Validation, PPAP, APQP Packages to third party auditors.
Ability to Understand Statistics as related to SPC, GR&R, MSA Studies
Lead-in customer, internal and registrar quality system audits.
Qualifications:
Minimum of 5 yrs. (equivalent) experience in product quality position, with direct experience PPAP/Validation Deliverables. Experience in medical device/life science (GxP) industry required.
Requires a 4-yr engineering degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning required.
Knowledge of quality inspection tools and methods required. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
Knowledge of GMP/ISO/21 CFR 820 Quality Systems required.
Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.
Knowledge of progressive metal stamping and/or insert molding processes desirable.
Target Compensation:
$100k-$120k salary (commensurate with experience) + a discretionary bonus.
Benefits:
Medical insurance
Vision insurance
401(k)
Seniority level: Mid-Senior level
Employment type: Full-time
Job function / Industries: Manufacturing and Medical Equipment Manufacturing
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