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Isometric Consulting is seeking an experienced and result-driven Quality Assurance Manager who will be responsible for developing, implementing, and leading quality control processes to ensure that products and services meet or exceed customer expectations and regulatory requirements.
As a QA manager, you will play a critical role in ensuring the quality of products and services, maintaining customer satisfaction, and complying with regulatory requirements.
You will lead quality control processes in the Medical device industry, develop and implement quality management systems, analyze quality data, and communicate quality objectives and outcomes to senior management and stakeholders.
Primary responsibilities:
- Design and develop or supervise the creation of quality control processes and procedures, including inspection and testing of protocols and the implementation and adjustment of quality assurance goals, objectives, and procedures to ensure that products and services meet regulatory requirements and customer expectations.
- Creating, updating, and managing records
- Managing the Medical Device QMS
- Creating the SOPs to support operational activities (including medical device sales, import and distribution)
- Coordination with third parties, including OEMs.
- Lead the testing and inspection of products and services, using tools and techniques such as statistical process control, root cause analysis, and failure mode and effect analysis.
- Manage the internal audit program and support external audits.
- Manage CAPAs, audit findings, and CAPA resolutions.
- ISO 13485 Gap Assessments
- Manage the MDSAP audit program.
- Support scope expansion to bring several new products to the company.
- Analyze quality data to identify trends, patterns, and opportunities for improvement, and develop recommendations for corrective and preventive actions.
- Manage quality assurance staff who fall under the following departments: production, inspection, process validation, quality control, labeling, and failure investigation.
- Collect, analyze, and summarize quality control and quality assurance trends and data; compile information into reports; and present reports.
- Travel on occasion to supervise work.
The ideal candidate will have a bachelor's degree in a relevant field, ISO 13485 Lead Auditor Certification, and up to 10 years of experience in the medical device manufacturing industry.
Education:
- Bachelor's (Preferred)
- ISO 13485 Lead Auditor Certification
Preferred Skills and Experience
- Familiarity with ISO 13485/MDSAP and sterile products is preferred.
- DHF and biocompatibility study skills
- Minimum of 10 years’ experience in the medical device industry.
- Strong attention to detail, accuracy in paperwork, and project management
- Excellent time management and task prioritization skills while working in a fast-paced environment.
- Well-developed interpersonal, communication, and teamwork skills.
- Strong leadership skills
- Highly developed problem-solving skills and techniques.
- Exceptional written and verbal communication skills.
- Ability to effectively use Microsoft Office applications at an advanced level.
- Organizational and time-management skills.
- Willing to work remotely.
- Willing to travel substantially.
Job Type: Contract
Pay: $25.00 - $45.00 per hour
Schedule:
- Monday to Friday
Education:
- Bachelor's (Required)
Experience:
- Medical device Industry: 10 years (Preferred)
- Dhf and Biocompatibility: 10 years (Required)
- Medical device QMS: 10 years (Required)
- Medical device internal & external audit: 7 years (Required)
- Managing CAPA resolutions: 7 years (Required)
- Managing MDSAP audits: 5 years (Preferred)
License/Certification:
- ISO 13485 Lead Auditor (Preferred)
Willingness to travel:
- 75% (Preferred)
Work Location: Remote
