Job Description

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

SUMMARY:

Our client is a world-renowned contract manufacturer of fine surgical components, cutting tools and accessories. As a surgical cutting tool manufacturer, they pride themselves in their technical versatility and ability to assist customers. They understand the fundamental requirement of superior performance from a surgical instrument and their team takes extreme pride in building quality products which provide a competitive edge for customers.

QUALITY ENGINEER: Quality is #1 and the Quality Engineers at our client make sure that happens every day. As a member of their Engineering team, you’ll play a direct part in the project lifecycle of product creation, production timelines, and quality standards.

LOCATION - Boyne City, MI

RESPONSIBILITIES:

• The development and execution of validation plans to support FDA, ISO and company standards.
• Creating and managing project tasks and schedules to support overall production scheduling.
• Supporting supplier audits to ensure capabilities and evaluate process change requests to align with both the company and customer requests.
• Performing hazard and risk analysis for new legacy products.
• Linking the efforts and communications of both the quality and operations personnel to ensure that inspection processes have been verified and documented.
• Identifying new inspection equipment.
• Leading the root cause analysis for any internal product quality issues or customer complaints.
• Mentoring and training team members.

EDUCATION:

• BS in Engineering required.
• 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 company.
• 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.

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