Quality Engineer

Imagine; Shakopee (MN); On-site; USD 80,000 - 110,000; Full time

Job summary

Imagine in Minnesota seeks a Quality Engineer to drive preventative quality measures for medical device customers and support QA functions across the organization. You will address customer quality complaints, ensure ISO 9001 compliance, and contribute to a total quality manufacturing environment.

You will lead SCARs and CAPA activities, maintain the QMS, and collaborate with customers and internal teams. Strong analytical and communication skills, plus experience in manufacturing quality, are

Qualifications

• Experience in supplier and/or customer quality in manufacturing.
• Experience with ISO 9001, Root Cause Analysis, SCARs and CAPAs.
• Bilingual or multilingual proficiency preferred (ASL included).

Responsibilities

• Lead timely completion of SCARs and CAPA activities with medical device customers.
• Collaborate with internal teams to own corrective actions (training, SOP updates, audits).
• Prepare and present reports and compliance documentation to medical customers.
• Maintain documentation for regulatory submissions and inspections.
• Ensure products meet FDA, ISO and other quality standards.
• Develop and maintain QMS to ISO 9001:2015 and company objectives.
• Provide guidance and training on medical quality standards to staff.
• Design inspection/testing plans; perform QA tests and data analysis.
• Lead cross-functional teams for root-cause analyses and CAPA closure.
• Support audits and customer quality visits.

Skills

Detail oriented

Communication skills

Analytical thinking

Root Cause Analysis

Six Sigma

MS Office

ISO 9001

Tools

Control charts

ANOVA charts

Sample size

Job description

Job Summary

The primary function of the Quality Engineer 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 competition 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.

Description

Job Summary

The primary function of the Quality Engineer 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 competition 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.

Job Description

• Work directly with our medical device customers to lead the timely completion of supplier corrective action requests (SCARs) and corrective action and preventative action (CAPS) 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; conduct 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.

Supervisory Responsibilities

• None

Requirements

Minimum Qualifications of Position

• Experience in supplier and/or customer quality in a manufacturing environment.
• Experience with ISO 9001, Root Cause Analysis, SCARs, and CAPAs.

Preferred Qualifications Of Position

• Bilingual or multilingual proficiency in any language (including ASL) preferred.

Knowledge And Skills

• Detail oriented with robust verbal and written communications 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.
• Working knowledge of Six Sigma methodologies.
• Robust skills in gathering and understanding data from systems.
• Must be self-motivated.
• Work well in a team and the ability to perform with little supervision.
• Follow and support all quality, management, and corporate policies and instructions.

Working Conditions And Physical Requirements

• Infrequent reaching, bending, and stooping.
• Ability to lift up to 50 pounds.
• Frequent standing, walking, and sitting.

EEO Statement

The Imagine Group provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.