Quality Engineer (MN)

Quality Engineer (MN)  

Full-time 

Mounds View, MN 

Pay 

$80,000 - $120,000 / year 

Description 

Excel Engineering is seeking a team-oriented, highly motivated?Quality Engineer?for our Mounds View, Minnesota office. We offer full service Engineering Consulting services in the US and abroad. 

Since 1990, Excel Engineering has differentiated its services from that of its competition by providing engineering solutions to achieve our clients’ business objectives. 

Primary Responsibilities 

• Participate as a quality representative in the execution and documentation of Validation Plans and Reports, User Requirements Specifications, Risk Assessments, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Standard Operating Procedures, and Validation Maintenance packages following existing procedures. 
• Approve change controls for compliance with existing requirements. 
• Own investigations and CAPAs relevant to responsibilities/expertise. Approve investigations and CAPAs relevant to all areas of the plant. 
• Lead teams in the execution of risk management activities using tools like FMEA or risk ranking to prioritize validation activities and mitigation strategies. 
• Ensure deliverables align with regulatory requirements including 21 CFR Part 11 and EU GMP Annex 11. 
• Maintain organized repositories of validation documentation and support audit readiness for internal and external inspections. 
• Act as a bridge between Quality Assurance, Validation, and Information Technology groups for the validation of computer systems. 

We offer a competitive salary and benefits package. 

Excel Engineering is focused on cultivating a high performing culture where a service oriented approach, continuous improvement, and goal orientation are valued. If you enjoy working in a fast paced, challenging and rewarding environment, Excel Engineering is for you! 

Excel Engineering is an Equal Opportunity Employer. Applicants will receive consideration for employment regardless of their race, color, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, or status with regard to public assistance. 

In our commitment to diversity, equity, and inclusion, we strongly encourage applicants from populations that are underrepresented in the engineering field to apply. For applicants who need an accommodation to apply, please contact human resources at [email protected]. 

Education and Experience 

• Bachelor's degree in science, engineering or other related technical field from an ABET Accredited Institution such as Chemical Engineering, Mechanical Engineering, Computer Engineering, or Electrical Engineering. 
• Cumulative GPA of 3.0 or higher on a 4.0 Scale. 
• 5+ years of related experience. 

Qualifications 

• Proficiency in writing and approving change control and risk assessments processes. 
• Experience applying cGMP principles to equipment, facility, utility, laboratory, and computer systems. 
• Knowledge of data integrity principles and ALCOA+ standards. 
• Experience with tech transfer and new product introduction (NPI) initiatives. 
• Experience with conducting risk assessments (e.g., FMEA, risk ranking). 
• Basic understanding of automation systems including PLC, DCS, and SCADA. 
• Engineer in Training (EIT) registration or ability to obtain such is highly preferred. 
• Ability to write and speak in the English language. 
• Willingness to travel up to 10% of the time. 

Additional Skills Applicable to the Role 

• Excellent interpersonal skills, as well as verbal and written communications. 
• Ability to work collaboratively with individuals at all levels in the organization in a team environment. 
• Knowledge of relevant technical software. 
• Knowledge of MS Office software products: Word/Excel/Outlook.