Quality Engineer Manager

Powerwell is a leading recruitment firm helping our clients discover top talent. We are recruiting for a Quality Engineer Manager.

JOB DESCRIPTION:

Responsible for daily tasks including quality checks on products, the use of multiple measuring tools, communication with leaders and team members, accurate documentation processes, internal audits, and customer audit preparation.

EDUCATION/EXPERIENCE:

· BS in Engineering required.

· 8 years’ experience in quality engineering and/or ASQ Certified Quality Engineer certification (preferred).

· Supervisor or leadership experience (preferred).

· Essential Functions, Knowledge and Competencies.

· Thorough understanding of current ISO 13485 and FDA QSR (21 CFR Part 820) requirements and how they relate to our client.

· Advanced understanding of GD&T and metrology.

· Proficient in various software applications (i.e. Microsoft Office and Minitab preferred).

· Must possess excellent documentation and technical writing capabilities.

· Independent self-starter who is capable of planning and managing multiple priorities.

· Ability to incorporate ASTM and ISO standards through the product life cycle, designing and developing the required inspection and process control methodologies.

· Must have excellent interpersonal skills, having the ability to interface with all levels of the organization, customers and suppliers.

· Thorough knowledge of analytical tools including Six Sigma, Lean and SPC.

· Ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with internal and external customers and solving project-related conflicts and issues.

· Strong supervisory and team building skills.

RESPONSIBILITY/AUTHORITY:

· Develop and execute verification and validation plans associated with product/process quality according to ISO, FDA and Precision Edge procedures.

· Create detailed and accurate project tasks and schedules, interfacing with internal and external customers and solving project related conflicts and issues.

· Support supplier audits to ensure capability, including correlation of inspection methods, and evaluation of proposed supplier process changes to our client and customer requirements.

· Support quality planning as necessary for product, including risk analysis for new and legacy products.

· Perform hazard and risk analysis for new legacy products, including FMEA and decision tree analysis.

· Act as liaison between QC personnel and operations personnel to ensure that inspection process capabilities have been verified and appropriately documented.

· Lead root cause analysis for customer complaints and internal product quality issues.

· Identify new inspection equipment to support production needs.

· Authorized to approve product realization (Quality Control) documentation in the absence of the Manufacturing and Quality Engineering Manager or Quality Manager.

· Develop and execute Measurement System Analysis.

· Mentor and develop Quality Department personnel.

· Train employees as needed.

BENEFITS:

Our client’s total rewards package includes market competitive benefits with day one coverage for medical / dental / vision / life / disability, a 401k plan that includes company matching contributions plus an annual company retirement contribution and annual Paid Time Off (PTO) along with company-paid holidays.