Quality Engineer Sr

Cretex Medical Component and Device Technologies; Dassel; Vor Ort; USD 97.000 - 123.000; Vollzeit

Zusammenfassung

An established industry player in the medical device sector is looking for a Senior Quality Engineer to enhance their quality assurance practices. This role involves defining and implementing quality-related processes, guiding teams through audits, and fostering a culture of continuous improvement. The ideal candidate will bring extensive experience in engineering and a strong understanding of regulatory standards. With a commitment to employee growth and a collaborative environment, this position offers a unique opportunity to make a significant impact in a company dedicated to saving lives through high-quality medical devices.

Leistungen

401k Retirement Savings Plan

Onsite Health Clinics

Discretionary Holiday Bonus

Employee Assistance Program

Wellness Program

Paid Holidays

Paid Time Off

Tuition Assistance Programs

Qualifikationen

• 10 years of engineering experience in machining or manufacturing settings.
• Knowledge of quality systems and regulatory requirements.

Aufgaben

• Develop inspection requirements and maintain quality documents.
• Act as quality interface for production teams and resolve issues.
• Conduct audits and create audit finding reports.

Kenntnisse

Leadership Skills

Verbal and Written Communication

Attention to Detail

Organizational Skills

Ability to Work in Fast-Paced Environment

Ausbildung

Bachelor’s Degree in Mechanical Engineering

Bachelor’s Degree in Industrial Engineering

Bachelor’s Degree in Physical Science

Tools

ERP Systems

Microsoft Office

Jobbeschreibung

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping, and device assembly. Learn more at www.cretexmedical.com.

Position Summary

The Quality Engineer Sr will be responsible for providing quality assurance support for manufacturing. This position is responsible for the definition, implementation, and improvement of quality-related practices and will provide technical guidance and measurement methodologies support.

Responsibilities

Essential Job Functions

1. Develop inspection requirements; facilitate PFMEAs; resolve discrepant material issues and create and maintain quality documents such as control plans and inspection plans.
2. Act as the quality interface for a production team in responding to customer complaints using failure analysis, development of corrective and preventative actions, and trend analysis.
3. Conduct audits, including closing out audit findings, create audit finding reports, and determine proper corrective and preventative actions.
4. Coach and mentor Quality Engineer levels I, II, and III.
5. Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge).
6. Lead and participate in large company-wide projects providing quality recommendations.
7. Partner with sister companies to implement best practices.
8. Support validation activity of processes, equipment, and metrology.
9. Ensure business systems are implemented, maintained, and functioning properly.
10. Support and comply with the company Quality System, ISO, and medical device requirements.
11. Read, understand, and follow work instructions and standard work.
12. Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance.

Qualifications

Requirements

1. Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science.
2. 10 years of experience in engineering in a machining or manufacturing setting.
3. Knowledge of quality systems, regulatory requirements, and industry standards.
4. Ability to consistently achieve short and long-term business results.
5. Demonstrate leadership skills.
6. Experience with ERP and quality systems.
7. Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
8. Clear and effective verbal and written communication skills.
9. Attention to detail.
10. Organizational skills.
11. Ability to work in a fast-paced team environment.

Desirable Criteria & Qualifications

1. Continuing Education; including participation in local chapters, associations, and/or organizations.

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety, and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of the things that employees have said about working for Cretex Medical:

• “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
• “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
• “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

Pay Range

USD $97,900.00 - USD $122,400.00 /Yr.

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+ hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in-network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long-term disability; company-provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.