Quality Engineer

Collabera; Columbia Heights (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading IT staffing firm in Columbia Heights seeks a Quality Assurance Specialist to support production quality assurance in a GMP environment. The role requires a Bachelor's degree in Engineering and 2-4 years of quality assurance experience. Responsibilities include ensuring product quality compliance, participating in audits, and collaborating across teams. Strong communication and analytical skills are essential. This opportunity offers a dynamic environment with a focus on career growth.

Qualifications

• Minimum 2 to 4 years quality assurance experience in a GMP environment.
• Experience working in a team environment.
• Must be able to communicate at all levels.

Responsibilities

• Provide comprehensive support to Operations in all areas of production quality assurance.
• Lead or actively participate in addressing issues that affect product quality.
• Actively participate in audits of the manufacturing operations.

Skills

Effective verbal and written communication

Analytical skills

Interpersonal skills

PC skills

Education

Bachelor's degree in Engineering discipline

Masters degree in engineering discipline

Tools

Statistical Knowledge

Word processing

Spreadsheets

Project management tools

Job description

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers.

Not only are we committed to meeting and exceeding our customer’s needs, but also are committed to our employees’ satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations.

For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit www.collabera.com to learn more about our latest job openings.

Awards and Recognitions

• Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012)
• Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013)
• Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US.

Job Description

Provide comprehensive support to Operations in all areas of production quality assurance.

Provide Quality support for the manufacture of legacy products. Support includes process improvements, product non-compliance analysis, and process changes.

Responsibilities include:

• Assure assigned product lines and manufacturing processes are to the highest quality and are compliant to internal and external regulations such as QSR 820 and ISO13485.
• Partner with manufacturing engineer to provide day-to-day support of assigned product lines. Actively participate in team meetings and daily status meetings. Provide support to the actual manufacturing line within the Clean Environmental Area.
• Lead or actively participate in addressing issues that affect the quality of the product and/or the manufacturing lines, such as analysis and disposition of non-conforming products. Identify opportunities for improvement of the product and/or the process.
• Actively participate in audits / assessments of the manufacturing operations, and recommends corrective / preventive actions and process improvements.
• Applies and understands statistical methodologies, as appropriate, for conformity assessment and investigative activities.
• Works with cross-functional groups to implement new products.
• Works with minimal supervision.

Qualifications

• Bachelor’s degree in Engineering discipline.
• Minimum 2 to 4 years quality assurance experience in a GMP environment or highly regulated industry with BS Degree. Minimum 0 to 2 years experience with Masters Degree.
• Experience working in a team environment.
• Effective verbal and written communication, analytical, influencing and interpersonal skills.
• Must be able to communicate at all levels and across company lines.
• PC skills, word processing, spreadsheets, project management, etc. Basic Statistical Knowledge and Application.
• Adhere to the Medtronic Core Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win.

Desired/Preferred Qualifications

• ASQC certification.
• Masters degree in engineering discipline.
• 4 or more years of quality assurance experience in a GMP, disposable medical device environment.
• Molding and software experience.

Additional Information

To know more about this opportunity, please contact: