Sr. Quality Engineer

Regulatory Jobs; BLOOMINGTON (MN); Vor Ort; USD 109.000 - 151.000; Vollzeit

Benefits dieser Stelle

401k with match

Onsite health clinics

Holiday bonus program

Cretex University

Employee assistance program

Wellness program

Death benefit

Sick and safe leave

Tuition assistance

Zusammenfassung

Quality Tech Services (QTS) in Minnesota is seeking a Senior Quality Engineer to provide QA support for manufacturing, drive quality systems, and lead improvement projects.

This full-time position will involve customer-facing activities, audits, corrective actions, and mentoring junior engineers, with a focus on regulatory compliance and continuous improvement.

Qualifikationen

• Bachelor’s degree in Mechanical, Industrial, or in another Engineering or Physical Science.
• 10 years of experience in engineering in a regulated industry manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Ability to consistently achieve short and long-term business results.
• Demonstrate leadership skills.
• Experience with ERP and quality systems.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• High attention to detail and good organizational skills.
• Ability to work in a fast-paced team environment.

Aufgaben

• Customer facing quality representative for the development project, complaints, and customer feedback.
• Develop and execute inspection methods; TMV/MSA protocols and reports, facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection documents and plans.
• 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.
• Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.
• Coach and mentor Quality Engineer levels, I, II, and III.
• Subject matter expert in one or more areas of the ASQ QE BOK.
• Lead and participate in large company-wide projects providing quality recommendations.
• Partner with sister companies to implement best practices.
• Support validation activity of processes, equipment, and metrology.
• Ensure business systems are implemented, maintained, and functioning properly.

Kenntnisse

Quality systems

ERP experience

Leadership

Communication

MS Office

Attention to detail

Team collaboration

Regulated manufacturing

Ausbildung

Bachelor’s degree in Mechanical/Industrial/Engineering/Physical Science

Tools

ERP software

MS Office

Jobbeschreibung

Overview

About QTS

QTS offers critical end-of-line services for medical device OEMs including finished device assembly, packaging and sterilization management. QTS is part of the Cretex Medical family of companies. Learn more at www.qtspackaging.com and www.cretexmedical.com.

Responsibilities

Senior Quality Engineer Ideal Candidate Profile

QTS is currently seeking an experienced, energetic, responsive and well-organized full-time Sr. Quality Engineer who will be responsible for providing quality assurance support for manufacturing. This position will also be responsible for the definition, implementation, and improvement of quality related practices and will provide technical guidance and measurement methodologies support.

Senior Quality Engineer Job Summary

• Customer facing quality representative for the development project, complaints, and customer feedback.
• Develop and execute inspection methods; TMV/MSA protocols and reports, facilitate PFMEAs; resolve discrepant material issues and create and maintain quality document such as control plans and inspection documents and plans.
• 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.
• Conduct internal audits, support external audits by regulatory bodies and customers, including closing out audit findings, create audit finding reports and determine proper corrective and preventative actions.
• Coach and mentor Quality Engineer levels, I, II, and III.
• Subject matter expert in one or more areas of the ASQ (American Society for Quality) QE BOK (Body of Knowledge).
• Lead and participate in large company-wide projects providing quality recommendations.
• Partner with sister companies to implement best practices.
• Support validation activity of processes, equipment, and metrology.
• Ensure business systems are implemented, maintained, and functioning properly.

Qualifications

Senior Quality Engineer Skills and Experience

• Bachelor’s Degree in Mechanical, Industrial, or in another Engineering or Physical Science.
• 10 years of experience in engineering in a regulated industry manufacturing setting.
• Knowledge of quality systems, regulatory requirements, and industry standards.
• Ability to consistently achieve short and long-term business results.
• Demonstrate leadership skills.
• Experience with ERP and quality systems.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher).
• Clear and effective verbal and written communication skills.
• High attention to detail and good organizational skills.
• Ability to work in a fast-paced team environment.

Desirable Criteria & Qualifications

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

What Is It Like to Work for QTS?

At QTS, we are passionate about quality as the services we provide have a direct impact on the quality of life for others and we pride ourselves on our culture and work environment. Here are some of things that employees have said about working at QTS:

• “I would describe my coworkers as kind and friendly.”
• “… I interned at QTS, then I went back to school… I was brought on as a shared service engineer, then I moved into a role with more customer interaction associated with it. All in all, a good, fun ride so far and I can’t wait to keep it going!”
• “Three words that I would use to describe QTS’s culture are: Respectful, Fast-paced, and Fun!”

We encourage you to explore the many opportunities that Quality Tech Services could offer you as an employee and as a valued team member.

Pay Range

USD $109,000.00 - USD $151,300.00 /Yr.

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

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.