Job Details

POSITION SUMMARY
In this position, you'll drive quality execution across medical device operations, including manufacturing, assembly, inspection, testing, packaging, and associated non-production-order-specific activities for commercial and product development products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Typical hours are 6a - 6p, on a 2-2-3 rotation.

Key Responsibilities:
• Perform daily quality assessments of facility, personnel, manufacturing activities, and documentation to uncover errors or deficiencies and assure quality and compliance with site procedures, the Quality Management System (QMS), cGMPs, and applicable medical device regulatory requirements.
• Interact daily with employees to assist with troubleshooting, documentation corrections/notes, and guidance on controlled manufacturing practices, contamination control, and adherence to approved work instructions.
• Champion a quality culture by helping personnel understand and apply QMS procedures, quality policies, process controls, and applicable regulatory requirements.
• Participate in quality event response (RAPID) and provide quality guidance for nonconformances, deviations, and other manufacturing quality events.
• Escalate nonconformance and deviation events to the appropriate functional and Quality management teams.
• Perform quality review and approval of procedures, work instructions, training documents, specifications, and forms of moderate to high complexity.
• Perform quality review and approval of nonconformances, deviations, CAPAs, and change controls of moderate to high complexity.
• Participate as the Quality Assurance representative in root cause analysis and investigations for nonconformances, deviations, complaints, and other quality events of moderate to high complexity, as applicable.
• Performs quality batch record review
• id in identifying continuous improvement opportunities and participate in practical process and quality system improvement initiatives.

Qualifications:
• Bachelor's degree, preferably in engineering, life sciences, technology, quality, or a related technical field required.
• Equivalent combinations of education, training, and relevant work experience may be considered
• minimum of 4 years of experience, with previous experience in Quality Assurance, Quality Control, Engineering, or Operations/Manufacturing.
• Previous experience in the medical device industry or another highly regulated manufacturing environment strongly preferred. Experience working within an ISO 13485-compliant quality management system and familiarity with applicable medical device regulatory requirements are preferred; experience in other regulated environments may be considered.
• bility to capture and analyze data and troubleshoot process, inspection/test, documentation, and equipment issues in partnership with production and technical leadership.
• Hard-working, demonstrated ownership & responsibility.
• bility to lead, support & empower a team/peers
• Professional certifications (ex: CQA) and training (Six Sigma) are a plus
• Primary responsibilities require consistent production floor presence, which necessitates physical fitness for prolonged standing, walking, and repetitive bending, as well as use of required personal protective equipment and gowning appropriate to controlled manufacturing areas.

Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."