Quality Manager

Job Description

Job DescriptionSalary: $90K-$115K

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):

• Structure the QMS requirements in accordance with ISO 13485
• Manages E-QMS software and E-QMS libraries in accordance with ISO 13485
• Manages workplace safety, quality control, quality assurance, and reviews internal and external systems.
• Decision maker for quality acceptance and communicates these decisions to department leaders so that they can support Injectechs goals and objectives.
• Directs the Quality Department actively including cleanroom deployed assets.
• Establishes the documentation of the companys quality procedures, standards, and specifications.
• Coordinates internal, external and ISO audit activities and addresses the results thereof.
• Communicates with customers on issues involving quality issues and opportunities.
• Manages quality systems training utilization and compliance.
• Manages certifications (ISO, etc.), customer and internal audits.
• Coordinates instruments and equipment calibration and certifications
• Coordinates the release of raw materials to production and disposition of non-conforming materials.
• Reviews customer requirements and makes sure they are met.
• Coordinates documentation of IQs, OQs, PQs, V&Vs and FMEAs
• Oversight of 6S program initiatives (with team)
• Engages in risk management evaluation and mitigation processes.
• Coordinates with Purchasing/AP/AR Administrator to establish quality requirements from external suppliers.
• Reviews and improves standards for quality, health, and safety.
• Ensures manufacturing processes meet all applicable standards and regulatory requirements.
• Introduces waste reduction and throughput improvement strategies.
• Defines quality procedures conducive to improving operational effectivity.
• Directs command and control of documentation procedures.
• Monitor performance based on relevant data and production of analytical reports.
• Promotes CPI activities and support implementation.
• Processing of Return Materials Authorization (RMAs)
• Educates assets, managerial, technical, etc. on use of quality tools for improvements to the business.
• Coordination, education, and implementation of inspection methods of molded and assembled parts.
• Maintain compliance with ISO and Good Documentation Practice (GDP) requirements within the Quality Assurance Department
• Assures that all work assigned is performed in accordance with instructions and requirements.

Manager Responsibilities:

• Assist HR department with hiring processes and new team member training.
• Set overall goals and objectives that align with Injectechs mission.
• Use planning, decision-making, and resource allocation to ensure an organized throughput of department.
• Allocate resources such as budget, personnel, and time to ensure that the team can achieve its goals efficiently.
• Make high-level decisions weighing various factors and considering risks that impact the team and department.
• Assess the performance of team members, provide feedback, create goals, and make decisions related to promotions, raises, and professional development.
• Mediate disputes to promote amicable and cooperative relationships among staff.
• Interact with other departments to ensure the teams objectives align with broader organizational goals.
• Assess risks and develop strategies to mitigate them to ensure overall success and sustainability of the department.
• Ensure safe working conditions and enforcing cleanliness in the department using 6S Lean.
• Monitor the department and the process to ensure that the finished product meets all quality, effectiveness, and customer satisfaction requirements.
• Attend manager meetings, conferences, and networking events when necessary.

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.

Qualifications:

• 7+ years of experience in an ISO regulated environment, highly regulated industry experience such as medical device, automotive, or aerospace required.
• 7+ years of related experience in quality and compliance, or equivalent combination of education, experience, and training required.
• 5+ years of leadership experience required.
• Strong working knowledge of MS Office Programs such Excel, Word, PowerPoint, etc.
• 3+ year experience in cleanroom setting required.
• Familiar with ISO regulated environment; highly regulated industry experience such as medical device, automotive, or aerospace is required.
• Knowledge of databases, E-QMS, ERP, and SAP systems required.
• Knowledge of SOPs, Work Instructions, and ISO 13485 standards required.
• Actively performs and understands Good Documentation Practices (GDP)
• Knowledge of design techniques, tools, and regulations involved in production of precision technical plans, blueprints, drawings, and models required.
• Must be proficient in math, science, and engineering.

Certifications (preferred):

• Six Sigma Green Belt (SSGB)
• Certified Quality Manager (CQM)
• Certified Quality Auditor (CQA)

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 and can work with multiple deadlines and commitments with little or no supervision.
• Detail oriented and organizational skills.
• Must be able to perform simple math such as addition, subtraction, multiplying, dividing, measuring and decimal points.
• Leadership and initiative skills
• Must have strong desire to promote efficiency and continual improvement processes.
• Adequate project management skills, including strong decision-making, problem solving and strategic planning abilities.
  

Benefits

Effective Immediately Upon Hire:

• 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.

Effective 30 Days After Hire:

• 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 race, color, religion, sex, national origin, age, disability, 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.