Take an idea. Make it a product. Get it into the pipeline. Share it with the world. Sounds simple, but, of course, the devil’s in the details. At Nike’s In-House Manufacturing and Distribution Divisions, we manage every detail, making sure great ideas become great products for athletes everywhere. What does this mean for you? In the best situations it means you’ll push your colleagues to do their best work, and they’ll turn around and do the same for you. And the details? Take a look and see for yourself.

As our Quality Assurance Engineer II, you’ll apply your engineering expertise to the development and implementation of IHM’s Quality system for new materials and manufacturing processes at our In-House Manufacturing facility in St.Charles, MO. You’ll work with the Product Creation teams, applying advanced Quality Engineering tools and statistical techniques to develop new materials and processes and identifying necessary improvements and controls. You’ll also develop and implement new materials and manufacturing processes to assure the quality of new products and processes. You’ll create and approve new product specifications by evaluating customer needs and statistically analyzing data generated during the product creation process using Design of Experiments and other advanced statistical tools. You’ll also train and direct Quality Auditors and Technicians on the performance of all process control and evaluation procedures. You’ll perform vendor/supplier Quality System evaluations and audits and establish and maintain product and process specifications for suppliers. This opportunity also involves designing and conducting process capability studies and other process evaluations to identify sources of variation, effectiveness of process controls and quality levels of products being produced while identifying and initiating improvements. In addition, you’ll direct investigations of defects and other reported problems to determine the cause and extent of the problems.

Requirements for the position include:
• Bachelor’s degree in Engineering or a related field
• 5+ years’ experience in a process engineering, quality engineering or a related role
• 2 years’ additional related work experience in lieu of a degree
• Demonstrated application of Statistical Process Control, Design of Experiments, problem- solving, quality planning and quality systems
• Demonstrated ability to train, monitor and coach other team members
• Ability to visually evaluate materials from a distance range of 12 inches to 6 feet and lift up to 35 lbs
• Experience with Infinity QS Statistical Process Control (SPC) software, Cadence, Microsoft Project or related project management software is preferred
• Experience working with LEAN Manufacturing techniques and implementation and thermoforming is strongly preferred
• Experience with an ISO9000 organization and manufacturing plastics and/or polyurethane is preferred
• Experience leading an organization through ISO 9000 or TS 16949 QMS registration strongly preferred
• Quality laboratory or other suitable supervision experience preferred
• Experience communicating technical/product information directly to external customers preferred
• Knowledge of EU/FDA or other regulatory product compliance requirements preferred

Interested yet? Good. Us too. We’re pretty sure you’ll want to know we offer one of the most generous benefits packages around. Things like a stock purchase plan, a 401(k) retirement plan, casual work environment, and a host of other perks we don’t have room to mention here.

We’re interested in learning more about you and appreciate you taking the time to apply online by clicking here.

Nike is committed to employing a diverse workforce. EOE/M/F/H/V

Contact: Lorraine.Woo@nike.com

Synergetics USA, Inc. is currently seeking a Senior Regulatory Specialist.

Synergetics USA, Inc. is a medical device company engaged in the design, manufacture, and marketing of microsurgical medical devices primarily for the ophthalmology and neurosurgery markets. The company’s principal product lines are designed for the microscopic delivery to a surgical site of laser energy, ultrasound, electrosurgery, aspiration, illumination and irrigation, alone or in multiple combinations.

Synergetics USA, Inc. is a public company and is the parent company of an international group of companies distributing medical devices around the world through direct sales employees, distributors, and independent sales representatives. The company is headquartered in O’Fallon, Missouri.

Position Summary:

The incumbent will have primary responsibility for the following activities: international product registration; approval of product labeling; compiling EU technical files/design dossiers; submission of 510(k)s; assessment and reporting of adverse events; management of recalls; post market surveillance; and the advising of personnel in other functional areas regarding compliance with QSR, cGMP, and other regulatory requirements.

Essential Duties & Responsibility

Maintain broad knowledge of 21 CFR Part 820, Part 11, and Parts 210 and 211; European Medical Device Directive 93/42/EEC; ISO 13485, and other quality standards;

Register products outside the U.S., working with foreign governments, distributors, and consultants;

Review and approve labeling to ensure regulatory compliance;

Compile and draft technical documentation, including design dossiers, EU technical files, 510(k)s, declarations of conformity, validation reports, and submissions to regulatory authorities domestically and internationally;

Perform post market surveillance,

Investigate and file reports on adverse events domestically and internationally;

Provide guidance for process validations, including sterilization;

Manage product recalls;

Qualifications:
ISO 13485/ 21 CFR Part 820, Quality System Regulation manufacturing background required.

Five to ten years regulatory experience, predominantly in medical devices, along with some pharmaceutical experience, in positions of increasing responsibility.

Bachelors Degree preferred or equivalent work experience.

ASQ Certified Quality Auditor or Engineer preferred.

Experience working with FDA, notified bodies, CSA, UL, foreign governments, and other regulatory agencies.

Website: synergeticsusa.com

Can send emails to: award@synergeticsusa.com