Job Description

Powerwell is a leading recruitment firm helping our clients discover top talent. We’re recruiting for a Quality Engineer III.

Job Description:

An experienced Quality Engineer III is responsible for in-depth understanding of blueprints, measuring equipment, documentation processes and clear communication with internal and external customers.

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, & 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 our client’s 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.

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

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.

• Benefits starting on Day 1
• 7% Shift Premium for second or third shift
• Competitive Pay
• Knowledge Based Promotions
• Company paid Short- and Long-Term Disability
• Company paid Life and AD&D Insurance
• PTO and Company Paid Holidays
• 401K with Company Match
• Climate Controlled, Clean Work Environment
• A successful candidate will have knowledge in or be able to achieve the below Job Qualifications.

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