Oriel STAT A MATRIX professionals come from a wide range of geographic and industry backgrounds and share the common goal of achieving success—personally and for our clients and our firm.
We are currently seeking candidates to fill following positions. Select a position to learn more.
- VP Sales
- Pharmaceutical Industry Sales Director
- Inside Sales Professional
- Medical Device Industry Sales Director
- Aerospace
- Medical Device
- Nuclear
Our corporate office in Edison, NJ is seeking a Practice Head to lead our FDA Regulated Practice. This role requires an individual who is both a thought leader and an experienced industry expert who can lead complex client engagements.
This role requires an individual who clearly understands current and future trends in the Medical Device and Pharmaceutical industries, can project the impact of these trends to understand current or imminent business challenges and design service offerings to assist industry in overcoming these challenges.
Principal Duties and Responsibilities:
- Act as thought leader in the medical device industry, keeping current with FDA/international regulations and leading our practice to support the industry.
- Assist top management in the design of strategies that support Oriel STAT A MATRIX corporate objectives.
- Work toward enhancing our current consulting methodologies and portfolio of training courses.
- Identify, propose, and manage new development (training and consulting) that will lead to the profitable growth of the practice.
- Manage the independent medical device affiliate pool including recommendations for hiring, training, monitoring performance, counseling, and terminating, as necessary.
- Provide technical support to the sales staff with respect to proposal preparation and sales calls.
- Assist marketing regarding the website and other material to ensure proper representation of our services for the medical device industry.
- Deliver training and consulting services (billable) to maintain “hands-on” experience as related to service quality and consistency.
- For large consulting projects, design the project plan and, as required, assume the role of program manager, leading/directing the consultant team throughout project execution.
Requirements:
- Must have 20+ years in Medical Device and/or Pharmaceutical Manufacturing
- Strong expertise related to quality/regulatory compliance.
- Must be proficient with ISO 13485 quality management system (QMS) standard, FDA quality system regulations, and the FDA quality system inspection technique (QSIT).
- Experience in medical device quality assurance, QMS auditing, quality control, design control, process validation, risk management and analysis, FDA 510 approval requirements, sterilization planning and purchasing controls preferred.
- RABQSA QMS auditor certification is a plus.
- Experience with other quality improvement disciplines, such as Lean, 6 Sigma, statistical process control methods, customer satisfaction, process management, etc. a plus.
- Prior experience as a facilitator/trainer a big plus.
Education:
- Engineering degree or equivalent degree relevant to FDA Regulated Industries
Personal attributes:
- Strong writing skills
- Strong communication/facilitation skills.
- Ability to work well in a team environment
- Leadership skills and ability to drive for results.
We offer a friendly and pleasant office work environment, work schedule flexibility, telecommuting (when business permits), a generous health benefits package including medical, dental, vision, FSA, life insurance and a 401(k) plan.
Please include compensation requirements/salary history with resume and forward to hr@orielstat.com
We are seeking six highly skilled, experienced professionals to join our sales team. Experience selling services including or similar to Lean Six Sigma, Performance Excellence, ISO 9000, Medical and Pharmaceutical Quality and Regulatory services is required. Please send your CV with salary requirements and the job code noted below to hr@orielstat.com
VP Sales
This position will lead a team of 11 internal and external salespeople, based across the country. Accountable to meet revenue and profit targets, this individual will be a member of a five-person executive management team. Past experience managing sales of consulting, on-site training, public training and licensing is required, as is an understanding of a solution based sales process which includes our offerings and methodologies. Familiarity with our target verticals is a plus. Location is either Edison, NJ or Indianapolis, IN. Base plus bonus. No relo. Email: hr@orielstat.com JobCode: VP
Pharmaceutical Industry Sales Director
We are expanding our offerings to include consulting and training for quality and regulatory professionals in the Pharma market. We are seeking two regionally based Sales Directors to build their regions from the ground up. This position requires tenacity and a desire to work in a start-up environment – we will not rest as we build this vertical. Heavy outbound calling is expected for the foreseeable future and travel is required. Experience selling to this segment is a definite plus. Edison, NJ or Indianapolis, IN based Directors are preferable, but home based is fine for the right candidate that can exceed their targets. Base plus performance bonus. Email: hr@orielstat.com JobCode: PH
Inside Sales Professional
We are seeking two Inside Sales Professionals to sell our Quality Management System Training and Consulting services. Focused on one geographic territory, these individuals will leverage our reputation and market share to increase our market share in ISO 9000, AS 9100, ISO 14000 and TS 16949. Expansion of existing client relationships will complement heavy outbound calling to grow your region. Edison, NJ or Indianapolis, IN based Professionals are preferable, but home based is fine for the right candidate that can exceed their targets. Base plus performance bonus. Email: hr@orielstat.com JobCode: IS
Medical Device Industry Sales Director
We are expanding our team supporting our very successful practice which provides consulting and training for quality and regulatory professionals in the Medical Device Industry. We are seeking one experience Sales Director to build their region. Heavy outbound calling is expected for the foreseeable future and travel is required. Experience selling to this segment is a definite plus. Edison, NJ or Indianapolis, IN based Directors are preferable, but home based is fine for the right candidate that can exceed their targets. Base plus performance bonus. Email: hr@orielstat.com JobCode: MD
Aerospace:
- Must have a minimum of 5 year experience in the industry in the last 10 years.
- Candidates must be an RABQSA certified lead QMS auditor.
- Aerospace Experienced Auditor certification is a plus.
- Must be proficient with AS9100C and AS9101D quality management system (QMS) and auditing standards.
- Experience in aerospace quality assurance, QMS auditing, quality control preferred.
- Experience in implementing and/or managing AS9100C QMS or Certification Body assignments desirable.
- Frequent travel required.
- Please submit a resume and brief cover letter with compensation requirements to hr@orielstat.com.
Medical Device:
- Must have a minimum of 5 year experience in the industry in the last 10 years.
- RABQSA QMS auditor certification certification is a plus.
- Must be proficient with ISO 13485 quality management system (QMS) standard, FDA quality system regulations, and the FDA quality system inspection technique (QSIT).
- Experience in medical device quality assurance, QMS auditing, quality control, design control, process validation, risk management and analysis, FDA 510 approval requirements, sterilization planning and purchasing controls preferred.
- Experience in implementing and/or managing an ISO 13485 QMS or Certification Body assignments desirable.
- Frequent travel required.
- Please submit a resume and brief cover letter with compensation requirements to hr@orielstat.com.
Nuclear:
- Must have a minimum of 5 year experience in the industry in the last 10 years.
- NQA-1 or the ANSI 45.2 certification is a plus.
- Must be proficient with 10CFR50, Appendix B Nuclear Quality Assurance Requirements), ASME NQA-1-2008, and N45.2.23 and other applicable nuclear (NRC and/or DOE) regulations.
- Experience in nuclear quality assurance, compliance auditing, quality control, design control, process validation, and risk management and analysis preferred.
- Experience in implementing and/or managing an 10CFR50, Appendix B system or Certification Body assignments desirable.
- Frequent travel required.
- Please submit a resume and brief cover letter with compensation requirements to hr@orielstat.com.