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Manufacturing Operations Manager
2 months ago
Avive Solutions, Inc. is a leading healthcare technology company that has developed an FDA-approved, next-generation Automated External Defibrillator (AED) and response system. We are seeking a highly skilled Manufacturing Operations Manager to join our dynamic team.
Key Responsibilities- Process Development and Implementation
- Design, implement, and validate manufacturing processes for production.
- Lead efforts to develop manufacturing processes and procedures from early R&D concept/prototype phase to high-volume manufacturing.
- Team Leadership
- Lead cross-functional teams to set up and qualify high-volume production facilities in compliance with common good manufacturing practices (CGMPs) and applicable FDA and ISO quality system regulations.
- Propose and execute growth strategies for the manufacturing team.
- Quality Assurance
- Comply with FDA 21 CFR Part 820 and ISO 13485:2016 quality system regulations.
- Author Material Specifications (MSs), Tool Specifications (TSs), Supply Specifications (SSs), Standard Test Methods (STMs), Bill of Material (BOM), Lot History Records (LHRs), Manufacturing Process Instructions (MPls) in compliance with common good manufacturing practices (CGMPs).
- Process Improvement
- Lead process improvement teams to analyze and improve existing processes using Lean Manufacturing principles.
- Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.
- Technical Expertise
- Use Statistical Process Control concepts and Minitab Statistical Analysis software to analyze process data.
- Author test protocols, perform testing, and author reports to support test method validation (TMV), design verification, design validation, process validation (IQ, OQ, PQ), intended use validation (IUV), flowcharts, PFMEA, DOE, Gage R&R in accordance with FDA and ISO quality system regulations.
- Communication and Collaboration
- Interface with Quality group to resolve Manufacturing-related CAPAs using different quality tools such as 5 Whys, cause and effect diagram, etc. and problem-solving methodologies such as Six Sigma.
- Contribute to operations functions outside areas of direct responsibility, including but not limited to Supplier Quality and support fulfilling requirements such as supplier assessments, audits, continuous improvement, etc.
- A Master's degree in Manufacturing Engineering, Mechanical Engineering, or a closely related field.
- One (1) year of experience in manufacturing engineering.
- Experience in manufacturing technologies/processes, automation/robotics, plant layout and material handling, Lean Manufacturing Principles, Six Sigma Problem Solving, Quality Control, and Statistical Process Control.
- Familiarity with FDA 21 CFR Part 820 and ISO 13485 Quality System Regulations.
Avive Solutions, Inc. offers a competitive salary range of $120,000-$160,000 annually, depending on experience. Telecommuting is allowed for this position.
We are an equal employment opportunity employer and welcome applications from diverse candidates. We provide reasonable accommodations for qualified individuals with disabilities.
