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Position Summary/ Objectives:
The Quality Associate will be responsible to verify that receiving, in-process and finished products comply with documented specifications. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.
Essential Job Functions:
- Conduct verification activities for receiving, in-process and finished products according to standard operating procedures
- Coordinate outside testing
- Identify and record any problems relating to the product, process, and quality system.
- Write and revise standard operational procedures, specifications, and other documents as necessary
- Provide support to Quality Document Control in processing/maintain the company’s documents
- Maintain quality records in accordance with documented procedures
- Provide support to Engineering such as writing protocols/reports
- Assist with various special ad hoc projects and other duties as assigned
Education, Experience, and Certification:
- Bachelor's Degree or equivalent in the biological sciences or engineering
- Good computer skills especially Microsoft Word and Excel
- Ability to follow written and oral instructions with minimum supervision
- Good communication skills, both verbal and written reports
- Experience in a medical device or science-related field is a plus
- Able to lift 30lb
- Able to work with flashing lights
Job location: on-site
At Innovative Health Sciences, we believe innovation starts with the patient. We are seeking an experienced Quality engineer to help drive our solution-based business model and take our designs to the next level. In this role, you will join our development team, managing projects from concept to completion, and ensure we are ensuring regulatory compliance and internal quality standards with our manufacturing and supply chain partners. Our ideal candidate is a creative thinker who shares our passion for making patient’s lives better.
- Conduct quality audits in accordance with ISO 13485
- Manage quality issues in conjunction with the CEO and CTO
- Oversee and perform quality assurance testing and in-process inspection
- Initiate corrective actions
- Identify continuous improvement opportunities and implement new processes
- Create production reports and training documents
- Oversee Engineering Change Orders (ECOs)
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Establishes statistical confidence by identifying sample size and acceptable error, and determining levels of confidence.
- Develops experiments by applying full and fractional factorial techniques.
- Develops sampling plans by applying attribute, variable, and sequential sampling methods.
- Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes.
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
- Prepares reports by collecting, analyzing, and summarizing data; and making recommendations.
- Prepare and execute protocols/reports as needed.
- Prepare and assist on Design Control documentation (e.g. DHF, FMEAs, design review)
- Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, benchmarking state-of-the-art practices, participating in professional societies, and maintaining ASQ-certified quality engineer qualification.
- Contributes to team effort by accomplishing related results as needed.
- Ensures products adhere to company and industry quality standards.
- Brainstorms ideas to create solutions for identified problems.
- Travel to customer and supplier locations as required.
Qualifications and Skills
- Development of inspection and work instructions
- Part inspection, including: layout, in process, final, and receiving using all types of mechanical inspection
- Preparation of inspection reports
- Coordination and performance of internal process/product audits
- Performance process capability studies
- Good oral and written communication skills
- Ability to communicate effectively with all levels of staff and management, both internal and external
- Capacity to work independently from general supervision (must be self-motivated once given direction/guidance)
- Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames
- Strong attention to detail
- Must be proficient in computer software: Microsoft Word, Excel, PowerPoint, Visio, Minitab, ERP, etc.
- Ability to read and interpret assembly and component drawings and engineering specifications
- CAD Data Analysis (measurement & manipulation) (CATIA V5 preferred)
- Basic knowledge of operating measurement equipment (CMM preferred)
- Lean Six Sigma Green Belt certification is a plus.
- Good knowledge of manufacturing processes
Education & Experience Requirements
- Bachelor’s degree in engineering or equivalent discipline or equivalent work experience
- 3+ years experience in a quality role within a medical device manufacturing environment
- Strong planning skills
- ASQ Certified Quality Engineer
- Root cause analysis experience preferred
- Above average math skills (sound knowledge in both statistics and calculus)
Experience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred
If you don’t see a position that coincides with your experience, don’t worry! Use the Contact Us page and submit your resume along with your contact information.