Quality Engineer - Katalyst Healthcares & Life Sciences

• 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.

• Health, dental, & vision insurance for employees, spouses, and dependent children up to age 26.

• Company-paid short- & long-term disability coverage.

• Company-paid life and AD&D insurance.

• Voluntary life insurance for employees, spouse, and dependent children up to age 18.

• Vacation pay accrues on a bi-weekly basis.

• Paid Holidays.

• 401k retirement savings plan with a 50% company matches up to a 3% match.

Requirements:

• BS in Engineering required.

• ASQ Certified Quality Engineer certification (preferred).

• Supervisor or leadership experience (preferred).

• 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.