Quality Assurance Engineer

At Imagine we go beyond print to help our clients deliver game-changing visual communications from concept to delivery that set the standard for our industry. The first step in this process is hiring great employees! Our innovative teams are the most committed, highly experienced artisans in the business. We are committed to delivering high-quality marketing solutions, in every environment and campaign, helping our clients capture the heart, minds, and loyalty of their customers. For more than 30 years, The Imagine Group has established itself as one of the most influential and innovative visual communications companies in the industry. Join us and let's Imagine a better way together.

Position Summary:

The primary function of the Quality Engineer - Medical Device role is to drive preventative quality measures that support the needs of our medical device customers. This position is expected to assist in other quality assurance functions, such as addressing customer quality complaints, ensuring compliance with certifications, and facilitating the completion of internal quality defects, helping to move the plant towards a total quality manufacturing facility. This position will work closely with our customers, as well as all levels of the company.

This is an onsite position out of our Shakopee, Minnesota office, Monday-Friday.

Essential Functions and Responsibilities:

• Work directly with our medical device customers to lead the timely completion of supplier corrective action requests (SCARs) and corrective action and preventive action (CAPA) activities.
• Collaborates with internal functions to own corrective actions which may include training, process improvements, SOP updates, quality audits, and validation efforts.
• Prepare and present reports and compliance documentation to medical customers as necessary.
• Maintain and review documentation for regulatory submissions and inspections related to product quality.
• Ensure products meet all regulatory requirements, including FDA, ISO, and other relevant quality standards.
• Assist in maintaining and developing our Quality Management System (QMS) to the requirements of ISO 9001:2015, Quality Manual, and current company objectives.
• Provide guidance and training on medical quality standards and best practices to internal teams.
• Design inspection and testing mechanisms; conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Lead cross-functional teams to perform root cause analysis events and ensure the completion of action items, which may include training, CAPA activities, quality audits, validation efforts, standard work revisions, etc.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate in companywide continuous improvement projects.
• Facilitate customer quality visits and support audits.

Mandatory Qualifications:

• Experience in supplier and/or customer quality in a manufacturing environment
• Experience with ISO 9001, Root Cause Analysis, SCARs, CAPAs
• Detail oriented with robust verbal and written communication skills
• Working knowledge of utilizing statistical analysis tools such as, control charts, ANOVA charts, sample size determination, etc.
• Robust analytical and problem-solving skills, with the ability to interpret complex data and provide actionable insights.
• Able to read and interpret written specifications and maintain documentation required internally and by the customer.
• Microsoft Office suite of products experience is required.
• Working knowledge of Six Sigma methodologies.
• Robust skills in gathering & understanding data from systems.

Preferred Qualifications:

• Must be self-motivated and the ability to prioritize tasks.
• Must work well in a team and the ability to perform with little supervision.
• Must follow and support all quality, management and corporate policies and instructions.
• Bilingual or multilingual proficiency in any language (including ASL) preferred

Physical Requirements:

• Infrequent reaching, bending, and stooping.
• Ability to lift up to 50 lbs.
• Frequent standing, walking and sitting.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The national pay range for this role is $75,000 - $110,000/year. The pay range may be slightly lower or higher based on the geographic location. The actual pay offered may vary based upon, but not limited to: education, skills, experience, proficiency, performance, shift and location. In addition to base salary, depending on the role, the total compensation package may also include participation in a bonus, commission or incentive program. Imagine offers benefits including medical, dental, and vision coverage, paid time off, disability insurance, 401(k) with match, life insurance and other voluntary supplemental insurance coverages, plus tuition assistance, caregiver leave, adoption assistance, and employer/partner discounts.

Imagine is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Diversity and Inclusion is not just a checked box, it is a critical part of our commitment to deliver innovative solutions to our clients and provide a great place to work for our entire Imagine family. We are focused on building a diverse and inclusive workforce. If you are excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.