Quality Engineer - ZipRecruiter : Job Details

Job DescriptionJob DescriptionSalary: $75,000-$110,000

Injectech, LLC has been a trusted supplier of fluid-control components for over 20 years. Our current senior management team has been with Injectech since the very beginning, bringing extensive knowledge of the medical device industry to every project.

Our Employees are important to us! We want the best for our employees, not just at work, but through all aspects of their life. That is why we pay 100% of the employees share of health insurance cost and match up to 6% for our 401k plan and provide free financial advice about retirement, debt, and any future financial needs from a licensed Financial Advisor. We strongly believe that the only way for our company to be successful is to make sure our employees have healthcare, mental healthcare, retirement options and financial education available to them.

We work hard to create a culture that promotes open lines of communication, a flexible work-life balance, continuous improvement in every department, and a place where employees want to be every day. We strive to hire and retain the best people, because we know a company is only as good as its employees. We hope you will join our team as we continue to grow and improve!

*Job role is on-site at our Fort Collins location.

General Duties (includes but not limited to):

• Ensure compliance to the ISO 13485 Standards and Injectechs Quality Management System (QMS).
• Desing, implement, and continuously evaluate quality assurance and control methods, systems, and procedures.
• Develop sampling plans and statistical techniques for manufacturing and inspection processes, including determination of control points and charting methods.
• Serve as Quality Engineering liaison to support both internal and external customer satisfaction, including the preparation of PPAP packages and related documentation.
• Identify, define, and recommend quality control issues for further analysis or improvement.
• Plan, execute, and follow up on gauge R&R studies, PPAPs, and product and process capability analyses.
• Conduct statistical analyses such as capability studies and Design of Eperiments (DOE).
• Generate and analyze reports related to product returns and quality metrics to identify trends and support continuous improvement.
• Support root cause analysis and implement corrective and preventative actions for internal processes, products, and customer concerns.
• Coordinate and participate in Material Review Board (MRB) activities to determine nonconforming product dispositions and associated corrective actions.
• Assist in the maintenance and organization of the document library and archives within SharePoint and SAP systems.
• Support the Quality Manager in the department and revision of inspection procedures.

Physical Requirements:

• Is expected to sit, walk, or stand for 8 hours per day.
• Must be able to communicate verbally, be able to hear, and have clear and corrected vision for tasks that involve reading, writing, and working with small details.
• Have physical agility for tasks that involve bending, kneeling, or reaching.
• Have precise hand-eye coordination for tasks that involve handling small objects, tools, or machinery.
• Must be able to lift and/or move 30-80 lbs.
• Comfortable working in environments with varying temperatures, noise levels, and exposure to industrial materials.

Qualifications:

• Bachelors degree in a relevant field or equivalent experience in a manufacturing environment.
• Minimum of 2 years of experience in an ISO-regulated industry; experience in medical device, automotive, or aerospace sectors is strongly .
• Hands-on experience with quality control inspection using calibrated measuring equipment is .
• Proficient in reading and interpreting technical drawings and specifications.
• Knowledge of Standard Operating Procedures (SOPs), Work Instructions, and ISO 13485 standards relevant to assigned responsibilities.
• Demonstrated understanding of ISO standards and Good Documentation Practices (GDP) within a quality assurance environment.

Skills:

• Ability to work in a team environment and willingness to maintain healthy working relationships.
• Demonstrates strong verbal, written, and interpersonal communication skills in English.
• Strong time management skills an can work with multiple deadlines and commitments with little to no supervision.
• Detail oriented and organizational skills.
• Must have strong desire to promote efficiency and continual improvement processes.
• Must be able to perform simple math such as addition, subtraction, multiplying, dividing, measuring and decimal points.

Benefits

• 401K Retirement Plan- Eligible to contribute starting the first of the month, 2 months after your hire date. Injectech matches up to 6% of your salary. Contributions are 100% invested immediately. Both Roth and Traditional options are available.
• Health Insurance- Coverage begins the first of the month after 30 days of employment. Injectech covers 100% of the employees' premium. You may add a spouse, domestic partner, or dependents at your own cost via pre-tax payroll deductions.
• Dental, Vision and Supplemental Insurance Plans- Offered at a group discount rate for employees, spouses, domestic partners, and dependents.
• Employee Assistance Program- Available to all employees and their family members at no cost.

• Sick Time- Accrues at 1 hour for every 30 hours worked, up to 48 hours per year.
• Paid Time Off (PTO)
  • First 36 months: 6.66 hours per month (up to 80 hours per year).
  • After 36 months: 8 hours per month (up to 96 hours per year).
  • Accrual rates continue to increase with tenure.
• Holiday Pay- 10 paid holidays per year.
• Voluntary Paid Time Off (VTO)- Up to 20 hours per year to volunteer at any 501(c)(3) nonprofit of your choice.
• Life and AD&D Insurance- Injectech provides a $50,000 policy at no cost to employees. Additional coverage is available for purchase.

Effective 6 Months After Hire Date:

• Profit Share Program- Eligible to participate the month following 6 full months of employment.

Drug Testing Policy

Injectech is committed to maintaining a safe and productive workplace. As part of this commitment, all potential employees must pass a drug screening as a condition of employment. The drug test is a 5-panel screening and must be completed prior to your start date.

Injectech is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to , , , , , , , or any other characteristic protected by law. We are committed to creating a diverse and inclusive workplace and encourage candidates from all backgrounds to apply.