Quality - Validation Engineer
Summary: Ensures the verification, validation, manufacturing and testing of products meets customer expectations, industry standards, quality and regulatory requirements; performs investigations and testing to resolve quality issues.
Essential Duties and Responsibilities:
- Develops and initiates quality plans from engineering drawings; meets company requirements for FDA and ISO design control as well as customer requirements.
- Determines gage and fixture requirements.
- Performs risk mitigations activities (PFMEA, Control Plans, Validations, Internal Audits and GR&R).
- Analyzes quality data, identifies problem areas, and assists in resolving manufacturing processes or methods that affect quality.
- Performs Design of Experiments.
- Assists with the inspection of components and final assemblies.
- Initiates and performs mechanical testing.
- Performs process capability studies; recommends changes to improve quality.
- Participates on cross functional teams to address and resolve quality problems.
- Acts as a liaison to resolve customer issues, both internal and external.
- Applies continuous improvement methods to enhance manufacturing processes, quality, reliability, and/or cost-effectiveness.
- Performs internal and supplier audits.
- Performs other assignments as necessary.
- Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers and regulatory agencies.
- Understands and complies with company policies and procedures, regulatory requirements and safety regulations.
- Regular attendance at work is required.
- Bachelor’s Degree in Mechanical or Biomedical Engineering or related field; two years of Quality Engineering experience; or equivalent combination of education and experience.
- Knowledge of manufacturing processes and testing methods.
Why Work at Gauthier Biomedical
If you’re looking for a great place to work, you just found it! In addition to numerous employment opportunities, Gauthier Biomedical offers a solid compensation and benefits package including...
We are committed to providing our employees and their family affordable, comprehensive insurance benefits. Eligible employees can elect:
- Health Insurance
- Dental Insurance
- Vision Insurance
In addition, we provide the following benefits at NO COST to our employees:
- Life/AD&D Insurance
- Short-Term Disability Insurance
- Critical Illness Insurance
- Wellness Benefits
Flexible Spending Accounts
Employees can allocate pre-tax dollars, via payroll deduction, to pay for eligible expenses through their HealthCare FSA and/or Dependent Care FSA.
401(k) Plan with Company Match
Eligible employees can elect to make Traditional Pre-Tax 401(k) contributions and/or as a Roth contribution (After-Tax) up to the annual IRS limits.
Gauthier Biomedical will make a Safe Harbor Matching Contribution equal to 100% of the employee contribution up to 3% of the employee’s compensation, and 50% of the employee contribution for the next 2% of their compensation.
Work Hours & Shift Premium
To accommodate our diverse workforce and family commitments, as well as business needs, we offer several different work schedule options. In addition, most of our positions are available as full-time or part-time opportunities.
Our full-time production employees are scheduled to work:
- 1st shift: 7:00AM – 3:30PM; Monday through Friday.
- 1st shift: 8:30AM – 5:00PM; Monday through Friday.
- 2nd shift: 3:30PM – 2:00AM; Monday through Thursday; 4 ten-hour days, plus a shift premium!
Personal Time Off (PTO)
Our PTO program combines vacation time, sick time and personal days off into one benefit, which starts accruing on the employee’s first day! This benefit allows employees to accrue 12 days of PTO to use during their first year.
We do not work on holidays! Our full-time employees receive 9 paid holidays each year to spend with their families.
Direct Deposit Payroll
No more running to the bank to cash your paycheck. Employees receive a secure, password protected email with their paystub information.
We support employees in their quest to improve their job-related skills and knowledge, and to acquire the education necessary to prepare for career-related promotional opportunities. Several training and development opportunities are available depending on your learning objectives and career goals.
No personal tools are necessary! Keep your tools at home and use them for your own projects. We supply the necessary tools for you to do your job here.
Onsite Fitness Center
We have an on-site fitness center where employees can use a variety of state-of-the-art fitness equipment.
We have numerous company events throughout the year. Not only do we have Dessert Competitions, Chili Cook-off contests, Halloween Costume parties, Thanksgiving Feasts, Corn Roasts, Brewers/Packer Parties, luncheons, etc., we also host March Madness and Ping Pong tournaments (Basketball & Ping Pong skills are not required). We’ve had fun planning new/unique events, such as a Car Show, Golf events and Pinewood Derby race. And, we typically end the year with a phenomenal Christmas Party at a local establishment. We are serious about fun!
Charitable Contributions and Sponsorships
We support our employees! What’s important to our employees, is important to us. Through employee suggestions, we have been a Corporate Sponsor for the MACC Fund and sponsored employee bowling teams. We have also sponsored teams in the Bastille Day Run and Turkey Trot, as well as other local community events. We’ve supported families through Holiday Gift Giving via Ozaukee Family Services, had winter coat drives to support Angels Among Us, sponsored the Boys & Girls Club fundraising activities, as well as countless financial charitable donations.
Great Work Environment
Gauthier Biomedical has state-of-the-art equipment and technology in our air-conditioned building. There is a courtyard in the center of our building for cookouts and outdoor lunchbreaks. We also have a Ping-Pong table and Pop-A-Shot game on the production floor for employees to use during breaks along with a Basketball court in the parking lot. We certainly know how to work hard and play hard!
We Support Our Future
We have participated on Marquette University’s Engineering Advisory Boards as well as offered Internships and Co-op opportunities to college students. We have hired and mentored high school students through County Youth Apprenticeship Programs. We have given tours to numerous local Technical Colleges and High Schools, as well as participated in Career Days and Expos, to generate interest in manufacturing careers to aspiring students.
Family Owned with Family Values
- Commitment to Excellence – We know how vital our jobs are. We continuously pursue innovative ideas and solutions that have the potential to make a difference.
- Teamwork - We are one team, no exceptions. We are a group of talented and diverse individuals unified by a clear common purpose. We treat each other with mutual respect, and we foster an environment of collaboration.
- Integrity – We maintain strong moral and ethical principles in all our actions; we do what is right.
- Personal Accountability – We deliver on our commitments; we take ownership of our performance, actions and decisions.
- Good Citizens – We are good citizens; we invest in the communities where we live and work.
See for yourself what makes Gauthier Biomedical a great place to work!
To apply, please email your Employment Application, resume and any additional supporting documentation to HR@gauthierbiomedical.com.
Application Process and Policy
If you are interested in working at Gauthier Biomedical and qualified for one of our current job openings, we encourage you to apply. To qualify as an Applicant, you must fully complete and sign our Employment Application.
Applications will only be accepted for jobs that we currently have open. You must specify the job(s) that you are applying for on the Application, or your Application will not be accepted. Applications submitted within 30 days of each other will be considered as one application. After receipt of your completed Application, Human Resources will review it to determine if your experience and educational background qualify you as a candidate for that position. If so, we will contact you to schedule an interview. Applications will be actively considered for 3 months; after that, an applicant will be required to re-apply if a position becomes available that you are interested in and qualified for.
Gauthier Biomedical is an equal opportunity employer, provides equal opportunities in all areas of employment, and does not discriminate on the basis of age, race, color, religion, creed, national origin, marital status, arrest or conviction record, sex, sexual orientation, gender identity/expression, ancestry or against qualified handicapped persons or qualified disabled veterans or veterans of the Vietnam era, or any other protected category, as required by law. If any reasonable accommodation is needed, please contact Human Resources at 262-546-0010 or firstname.lastname@example.org.
Thank you for your interest in working for Gauthier Biomedical.