Quality Systems Manager

My client is a leading Medical Device Manufacturer and are growing! They are looking to add a Quality Systems Manager who will be responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following: program management and measurement of machined product and fixtures/tooling, progressive stamped parts, and tooling, insert molding parts and tooling, factory assembled automation, and other related tooling/processes.

Compensation Up To $160,000

Other Benefits Include

Medical, Dental and Vision
401 (k) with company match
Holiday, Vacation and Sick Time
Tuition Reimbursement
Health Savings Accounts (HAS)
Flexible Spending Accounts (FSA)
Cigna Wellness Incentive Program
Employee Assistance Program (EAP)
Short Term Disability
Group Life and Accidental Insurance
Sun Life – Accident, Critical Illness, and Hospital Indemnity Insurance
Smoking Cessation Program
Pet Insurance

Responsibilities:

Represent the customer in order to ensure that the customer’s expectations are clearly understood and being met.
Provide leadership to technical teams responsible for successful launch of multiple complex programs.
Service and grow our program base within the Medical / Life Science Industry (Technical Sales)
Responsible for overseeing the coordination and on-time/in-budget completion of all projects which may involve some or all of the following: program management and measurement of machined product and fixtures/tooling, progressive stamped parts and tooling, insert molding parts and tooling, factory assembled automation, and other related tooling/processes.
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 Weiss-Aug Manufacturing technologies.
Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities, monitor progress and report status to management/customer.
Facilitate Tooling Kickoff, Specification Review, Design Review and Lessons Learned (Post Mortem) Meetings.
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.
Execute Engineering Studies on Existing and New Programs to facilitate and part optimization and debug.

Requirements:

Requires a 4-yr engineering, technical or management degree or substitute experience; graduate degree in engineering, technical or management discipline is preferred.
Minimum of 5 yrs. experience in program management/technical project management and/or manufacturing and/or product design (R&D) environment. Experience in medical device/life science industry required.
Experience with product design, program/project management, and understanding of tight-tolerance manufactured products is required.
Ability to read blueprints and other technical documents. Understanding of ANSI/ISO drawing standards and GD&T dimensioning preferable.
Ability to use SolidWorks for product/tooling design preferable.
Knowledge of quality inspection tools and methods preferable. Familiarity with Statistical Process Control (SPC) tools and methods also preferable.
Knowledge of GMP/ISO Quality Systems required.
Knowledge of TQM, Six Sigma or Lean Manufacturing principles preferable.