Quality Assurance Engineer

2 weeks ago


Grand Rapids, Michigan, United States Grand River Aseptic Manufacturing Full time
Core Values:
Integrity, Service, Teamwork, Bravery.

Are these principles that resonate with you? Do you aspire to be part of a community that values making a positive impact? Are you seeking an environment that fosters growth and learning within a diverse and community-focused culture? If so, Grand River Aseptic Manufacturing (GRAM) invites you to explore a career with us, where dedicated professionals strive to enhance lives every day.


Position Overview:
The Quality Assurance Engineer plays a pivotal role in ensuring that the Facilities Engineering & Maintenance teams adhere to all quality standards.

Your responsibilities will include driving the fulfillment of departmental commitments through our document management system and overseeing the NCR, CAPA, and Change Control processes.

Collaborate with Operations and Quality teams as an engineering expert focused on conducting investigations and root cause analyses using effective problem-solving techniques.

Work alongside engineers and technicians to implement enhancements in systems and practices. Develop and deliver procedures, job aids, work instructions, and training programs to elevate quality across the department.

Essential Qualifications:
Bachelor's degree in a STEM field or Quality Assurance.

3-5 years of experience in a highly regulated setting.

Training in Continuous Improvement/Six Sigma.

Strong proficiency in Microsoft Word, Excel, and Outlook.

Preferred Qualifications:
Experience in the pharmaceutical industry is advantageous.

Greenbelt certification is a plus.

Background in root cause analysis and/or forensic engineering is desirable.

Key Responsibilities:
Monitor, track, and fulfill Engineering & Maintenance quality obligations.


Act as the primary liaison within the department for corrective and preventive actions (CAPA), non-conformance reports (NCR), and change controls.

Ensure timely completion of departmental action items.

Collaborate closely with Quality and departmental leaders to establish metrics, assess departmental quality performance, and drive results.

Provide training to engineers and technicians on quality-related subjects and offer guidance to ensure tasks are completed accurately.


Review and approve completed eMaint work orders in the computerized maintenance management system (CMMS) for compliance with standard operating procedures, completeness, and accuracy.

A comprehensive job description will be available during the formal interview process.

What Distinguishes GRAM from Other Employers:

MEDICAL BENEFITS starting from day one:

Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family from your first day of employment, with the company covering 75% of the costs. Once eligible for the 401(k) program, all contributions are immediately 100% vested, and you are also immediately vested in GRAM contributions.

We also provide generous off-shift premiums.

PAID VOLUNTEERISM from day one:
GRAM encourages community involvement by offering 16 hours of paid volunteer time each calendar year.

PTO:
Full-time employees accrue up to 17 days of paid time off per calendar year, which can be utilized for vacation, illness, or mental health needs.

PAID HOLIDAYS:
We offer 8 paid holidays per calendar year with immediate eligibility.

COMPENSATION:
Salary is commensurate with experience and will be discussed during the interview process.

If you meet the required qualifications outlined above, GRAM encourages you to consider this opportunity.

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