Location: Oakdale, MN
Role: Quality Control Analyst
Position: Immediate Contract Available One Year - Possible Hire
At Helius Medical, Inc (HMI) our purpose is to provide breakthrough technologies as potential treatment for neurological symptoms caused by disease or trauma. With the clearance of our PoNS device US, Canada, and Australia, Helius Medical, Inc (HMI) is scaling our manufacturing and distribution capabilities to serve a large and diverse customer base.
This is an exciting opportunity for a highly competent quality control engineer (QCE) professional with deep experience in electromedical devices in a manufacturing setting. Superb technical and people skills are needed in this QCE role in order to successfully lead all aspects of quality while located at our contract manufacturer.
This onsite, hands-on, manufacturing QCE role is critical to HMI’s business by being responsible for all aspects of electromedical device manufacturing quality assurance and production & process control: incoming inspection, manufacturing/in-process, final test and final inspection. The QCE conducts data analysis, trending, and reporting. The QCE manages nonconformities and corrective and preventive actions at the factory in concert with the contract manufacturer. The QCE also leads manufacturing process verification and validation activities and supports audits.
MS Office, highly proficient using MS Excel with statistics module, MiniTab preferred,
LEAN practitioner preferred
ASQ certifications preferred
Six sigma black belt preferred
Essential Duties and Responsibilities:
- Ensure compliance with all aspects of applied regulations, standards, guidance, and HMI’s QMS through close oversight and effective management of the contract manufacturer’s (CM) activities affecting HMI products
- Oversees CM in inspection and test of components, subassemblies, and finish product, directs employees/partners involved in incoming inspection, manufacturing and in-process inspections and testing, and final test and final inspection to assure the require quality control levels are achieved through procedures and results properly documented
- Identifies and investigates all quality issues likely to affect manufacturing compliance and product quality, identifies root cause(s) and recommend appropriate actions
- Develops inspection and testing methods and participates in the preparation of quality assurance plans, specifications and procedures
- Conducts training and audits
- On-site leadership of product and process Corrective and Preventive Action (CAPA) investigations from identification and issuance through to implementation of solutions. Monitor and assess actions for effectiveness and report results to management. Conduct root cause analysis to understand and resolve product and process issues. Manages third-party suppliers accordingly.
- Actively participates as SME in the review of engineering specifications, protocols, and reports to assure that adequate quality assurance requirements are met, and designs are adequately transferred into manufacturing with high process capability measured against critical to quality design output
- Acts as on site lead during audits and ensures preparation with respect to 21CFR 820, ISO 13485, ISO 14971 and International regulatory requirements.
Minimum Qualifications & Skills Required:
- Eight years of manufacturing quality control experience in electromedical device industry, minimum 5 years in manufacturing setting
- Experienced with the application and implementation of GMP/QSR/ISO 13485/MDD/MDR and Canadian Medical Device regulations a plus
- Expert knowledge of Quality Systems Regulation, Standards, and guidance; 21 CFR Part 820 (Part 210 & 211 knowledge/experience is a plus), ISO 13485, MDSAP, ISO 14971
- Extensive experience in addressing Corrective Actions: ability to investigate, understand, review and document complex production issues. Ability to effectively communicate technical findings and write technical reports.
- Excellent problem-solving and troubleshooting skills
- ASQ certification (e.g., CQE, SSBB, SSGB, CQA, etc.) strongly preferred
- Extensive practical knowledge of quality engineering and design controls and development activities for medical devices
- In-depth knowledge of the concepts of productions & process control, engineering change control, statistical techniques, process verification & validation, risk management
- Experience auditing and managing device history and device master records (DHR/DMR)
- Audit leadership experience
- Quality engineering tools required: DOEs, process control system measures, statistics, sampling plans, quality plans, calibration, verification, validation
- Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), along with quality tools such as Minitab for statistical analysis required
- Experience with Dynamics or other ERP systems knowledge a plus
- Ability to communicate effectively, verbal and written
- Must be able to work under minimal supervision on somewhat ambiguous tasks; ability to work on problems with limited direction.