Engineer, OEM Quality
Gyrus ACMI - Southborough, MA

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Olympus Surgical Technologies of America (OSTA) is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technologies of America (OSTA) is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technologies of America (OSTA), believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technologies of America (OSTA) is committed to creating a world class company with world class people.

Position Description:
Southborough, MA - The Engineer, OEM Quality will evaluate quality concerns with OEM products, support validations, and new product development involving OEM Suppliers. The incumbent will provide guidance to OEM suppliers to prevent the recurrence of existing and new product concerns and drive exceptional product quality for the patient safety and customer value beyond expectations. EOE M/F/D/V

Requirements and Responsibilities:
* Evaluate quality concerns of the performance of devices and components from the supplier and/or field.

* Initiate and review responses to supplier corrective action requests (SCARs) and quality concerns.

* Evaluate root cause to drive corrective and/or preventive action.

* Interface with supply chain, engineering, purchasing, and receiving inspection regarding OEM supplier nonconformances.

* Perform OEM supplier quality audits.

* Support OEM supplier evaluation process, including performance monitoring and supplier scorecards.

* Support OEM supplier corrective action and preventive action (CAPA) initiatives, including preparing OEM CAPA Board metrics and meeting slide decks.

* Interface with all areas of New Product Development (NPD) and OEM Inspection Process.

* Support NPD project team risk management deliverables, such as risk considerations, hazard analysis, D/PFMEAs, and risk management reporting.

* Support NPD project teams in reviewing user requirements and product performance specifications, as well as, IQ, OQ, PQ protocols and reports.

* Support NPD project teams on new and existing product and process development activities.

* Review OEM product performance testing concerns, including First Article Inspections, and supplier nonconformances as required.

* Assist in developing, implementing, maintaining, and monitoring the OEM finished product inspection process, including sample sizes and inspection procedures.

* Participate in development and implementation of quality policies and procedures.

* Participate in developing necessary quality policies and quality procedures.

* Participate in developing programs or projects that enhance the quality and

improve the incoming inspection of OEM products.

* Assist in the implementation, compliance, and maintenance of FDA, ISO 13485, ISO 14971, Canadian, and European MDD requirements.

* Evaluate quality concerns of the performance of devices and components from the supplier and/or field.

* Initiate and review responses to supplier corrective action requests (SCARs) and quality concerns.

* Evaluate root cause to drive corrective and/or preventive action.

* Interface with supply chain, engineering, purchasing, and receiving inspection regarding OEM supplier nonconformances.

* Perform OEM supplier quality audits.

* Support OEM supplier evaluation process, including performance monitoring and supplier scorecards.

* Support OEM supplier corrective action and preventive action (CAPA) initiatives, including preparing OEM CAPA Board metrics and meeting slide decks.

* Interface with all areas of New Product Development (NPD) and OEM Inspection Process.

* Support NPD project team risk management deliverables, e.g., risk considerations, hazard analysis, D/PFMEAs, risk management reporting.

* Support NPD project teams in reviewing user requirements and product performance specifications, as well as, IQ, OQ, PQ protocols and reports.

* Support NPD project teams on new and existing product and process development activities.

* Review OEM product performance testing concerns, including First Article Inspections, and supplier nonconformances as required.

* Assist in developing, implementing, maintaining, and monitoring the OEM finished product inspection process, including sample sizes and inspection procedures.

* Participate in development and implementation of quality policies and procedures.

* Participate in developing necessary quality policies and quality procedures.

* Participate in developing programs or projects that enhance the quality and

improve the incoming inspection of OEM products.

* Assist in the implementation, compliance, and maintenance of FDA, ISO 13485, ISO 14971, Canadian, and European MDD requirements.

* Perform other related duties as assigned.

Qualifications:
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)

* A Bachelor's Degree in Engineering or technical discipline is required; or a non-technical degree plus 3-5 years of quality assurance experience in medical device is required.

* A minimum of 3-5 years of experience in medical device related to quality assurance, quality engineering, supplier quality, risk management, design validation and verification, and process validation is required.

* Must have a detailed knowledge of FDA QSR, GMP, ISO 13485, ISO 14971, Canadian, and European MDD regulations/requirements.

* Must be willing to travel domestically and/or internationally up to 25% of time and have the ability to travel on short notice.

* American Society for Quality Certified Quality Engineer (CQE) and/or Certified Biomedical Auditor (CBA) is preferred.

* Must have strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

* Proficiency with Microsoft Word and Excel spread sheet development and analysis, including statistical/data analysis and report writing skills is necessary.

* Must have the ability to perform multiple tasks concurrently with accuracy.

* Must have strong attention to detail.

* Well developed organizational and problem solving skills are essential.

* Must have strong interpersonal skills.

* The ability to communicate effectively, both verbally and written, is necessary.

* Must have the ability to speak effectively before groups of employees of the organization and suppliers.

* Must have the ability to read and interpret documents such as prints and inspection procedures.

* The ability to write routine reports and/or correspondence clearly and accurately is essential.

* Must have the ability to prioritize multiple tasks.

* The ability to work well within teams, independently, and with minimal supervision is necessary.

* Must have the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

* The ability to compute rate, ratio, and percent and to draw and interpret bar graphs is essential.

* Must have the ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form.

* Proficiency in MS Office, Word, Excel, and PowerPoint is preferred.

* The following physical demand is required:

-Stand/Sit/Walk 8 hour a day

* The following work environment condition exists:

-Infectious Disease exposure

Olympus - 10 months ago - save job
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About this company
5 reviews
Gyrus ACMI allows surgeons to see better and do less tissue damage to their patients. A subsidiary of Olympus, the company makes medical...