Quantimetrix Corporation Redondo Beach, a leading healthcare company in clinical diagnostics, is seeking candidates for the following positions (only local candidates will be considered):
Sales Representative
Major Responsibilities
- Domestic distributor account management with an emphasis on increasing sales to meet annual forecast
- Develop new direct customer accounts
- Increase sales of existing customer accounts
- Develop new OEM accounts
- Maintain daily CRM records
- Fulfill literature and sample requests
- Make presentations of sales activities to executive management
- Travel to trade shows and key accounts
- Maintain knowledge of industry trends and competition
- Contribute to a positive work environment with an emphasis on teamwork
Qualifications
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Bachelor’s degree in science or medical technology
- 5 years of sales or cold calling experience preferably within the healthcare/pharmaceutical or biotech industries
- Excellent phone personality, verbal and written communication skills
- Strong analytical and organizational skills
- Knowledge of Microsoft Office, CRM, and internet applications
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| Quality Assurance/Quality Control |
Quality Engineer
Major Responsibilities
- Provides focused hands-on validation & quality engineering support to R&D, Manufacturing and Quality Control.
- Continually seeks to drive improvements in product and process quality.
- Conducts FMEA, raw material characterization, risk management and equipment method validations.
- Utilizes standard statistical analysis and problem solving techniques to determine product acceptance, evaluate process capabilities and assist R&D in Design Control and process transfer to Manufacturing.
- Participates in design reviews for new product development and design/process changes.
- Prepares & Reviews Validation protocols and final reports (IQ, OQ, PQ).
- Prepares SOPs and inspection/test methods and other change control related documentation.
- Prepares Master Validation Plans and participates in process qualifications.
- Responsible for ensuring all quality standards and specification are defined and achieved in line with appropriate regulatory requirements, especially the FDA Quality System Regulation and ISO 13485:2003.
- Fully participates in and successfully contributes to project teams typically including the following activities: product design and development, test of materials, preparation of specifications, process capability studies, research investigations, report preparation, and process/test documentation.
- Perform other tasks and duties as directed by the Director of Quality Assurance and Regulatory Affairs.
- Assist in maintaining Quantimetrix Corporation quality system.
Qualifications
- B.S. in related fields or equivalent, science or Engineering preferred.
- Minimum of 5+ years experience as a Quality engineer in a medical device / in vitro diagnostic manufacturing environment, with a minimum of 1 year as a lead or senior quality engineer.
- Strong knowledge and hands-on experience in the application and implementation of (GMP/QSR/ISO/MDD).
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Quality Assurance Associate
Major Responsibilities
- Create and review Quality System documentation.
- Assist with process and product validation.
- Lead and assist in CAPA process, root cause analysis and corrective action determinations to provide resolution to consumer complaints, audit observations, non-conforming material dispositions, and process variation.
- Assist in preparation of Medical Device Reports.
- Trending and statistical analysis of key quality indicators to support management review.
- Coordinate internal and supplier audit findings.
- Provide support in quality engineering matters.
Qualifications
- B.S. in related field or equivalent, Science or Engineering preferred.
- Minimum of 3-5 years as a Quality Engineer or other similar position in an FDA regulated industry.
- Must have strong written/verbal communication and presentation skills.
- Requires strong analytical skills and problem solving abilities.
- Ability to handle multiple projects simultaneously.
- Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.
- Requires experience with MS Word, Excel, PowerPoint and statistics applications.
- Experience with FDA audits or regulated body audits such as ISO a plus.
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