Quality Systems Specialist

Velosity Forest Lake is searching for a Quality Systems Specialist to support our Forest Lake, MN location. The Quality Systems Specialist (QSS) is a corporate level role that will be primarily assigned responsibility at a single site, however, may be asked to support specific initiatives across the organization. The QSS will be tasked with supporting Supplier Management, Audits, Quality Systems, and Document Control systems as required. The tasks involved with this role may include (but are not limited to): audit plans and reports; CAPA/Complaint/Nonconforming Material summary data, Supplier Corrective Action support, and Document Control activities as necessary.

The typical pay range for this role: $22.97-$34.46/hour. This role is also eligible for our 5% quarterly bonus target.

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The compensation that will be offered to the successful candidate will depend on a variety of factors including experience, education, geography, internal equity and other relevant factors.

This position includes a comprehensive benefits package that includes:

• Insurance: Medical, dental, vision, life and disability plans.
• Other Benefits Include: 401(k) with company match, PTO, holidays, and paid parental leave.

This is an on-site position supporting our Forest Lake location.

Who is Velosity?

Velosity Forest Lake is not your typical manufacturing company.

Founded in 1972, we are a state-of-the-art, custom contract manufacturer and injection molder providing creative solutions to our customers' unique manufacturing challenges.

At Velosity, our culture & values are our competitive advantage. Engrained in everything we do are our values of Collaboration, Results-Driven, Continuous Improvement, Integrity, and Customer Satisfaction. Sound like you? Apply to join our team today.

What You'll Love about Velosity:

• Excellent benefits package including medical, dental, life insurance, short term and long-term disability, flex spending, 401k match, and MORE!
• Quarterly bonus opportunity
• Generous PTO offerings & 9 paid holidays annually
• Great opportunities for growth & advancement
• Clean, friendly, and air-conditioned work environment
• A collaborative employee centric environment that hires and develops talent based on our values
• Casual Dress Code

Requirements:

• High School Diploma/GED
• Valid identification and the ability to work legally in the United States.
• Minimum of 3-5 years working in a regulated industry (medical or aerospace preferred). The preferred candidate will have some experience working in the areas of Supplier Management, Quality Systems Audits, Quality Systems (CAPA, Complaints, Nonconforming Materials), and/or Document Control.
• Basic computer skills, such as Microsoft Office (Word, Excel, PowerPoint).
• Knowledge of ISO, FDA, and cGMP concepts and guidelines.
• Knowledge of computer-based Quality Management Systems (examples include IQMS, Grand Avenue, Windchill) and ERP systems (IQMS, Epicor, SAP, etc)
• Keen attention to detail and schedule; ability to use task organizational tools (task lists, MS Project) is a definite plus.

Essential Functions:

• Manage and/or perform internal, external, and supplier audits to ISO 13485:2016, ISO 9001:2015, AS9100D, and/or other standards as applicable.
• Support internal and external audits across the company.
• Assist in the completion of site and corporate level Management Reviews.
• Perform Supplier Management qualification and maintenance activities in conjunction with the Purchasing group.
• Manage Supplier Corrective Action Requests (SCARs) with our vendors.
• Manage material certification requests for our customers.
• Manage CAPA, Complaint, and Nonconforming Material Review Boards at the site level.
• Manage calibration and environmental monitoring cycles for affected equipment and facilities.
• Review and approve calibration records and environmental certification/monitoring reports, and initiate any follow-on records as required.
• Provide additional Quality Systems support to the sites as needed for the Document Control function.
• Other duties as assigned

Physical & Mental Demands:

• Walking is required within the office/shop areas. Sitting, standing, turning the head and torso, reaching, grasping, bending and flexing the arms, legs, wrists, and fingers are physical requirements. Must have correctable eyesight and good depth perception. Must be able to sit for long periods of time. Must be able to walk, sit and occasionally climb and balance. Must be able to lift 10 pounds and move objects in a safe manner using proper equipment. Must have dexterity with hands.

The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Work Environment:

This is a non-smoking, professional tool shop with normal lighting, and climate control. This position requires the employee to work on a manufacturing floor where they may be subject to airborne contaminants and chemical odors.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Protective Clothing Required:

When in certain locations of the facility, eye and ear protection are required. Closed-toed/ Slip resistant shoes are also required in certain locations.

We are proud to be an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, veteran, marital, or disability status.

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Velostiy is an E-Verify employer.

Velosity maintains ITAR-compliant operations in our facilities. Due to ITAR regulations, this role is only open to U.S. Citizens, lawful permanent residents (green card holders) or foreign nationals granted refugee or asylee status. Individuals with temporary visas (e.g. E, F-1, H-1, H-2, L, B, J, TN or OPT) are not eligible for hire in this role.