Synergetics is a growing designer, manufacturer, and distributor of microsurgical instruments and capital equipment used primarily in vitreoretinal surgery and neurosurgical applications. We are currently seeking a Quality Engineer for our O’Fallon, Missouri facility.

The ideal candidate will possess a strong knowledge of process validation, FMEA/risk analysis, SPC, structured problem solving, and MS Access and Excel. Experience with error proofing, automated inspection techniques, and line layout / increasing work flow efficiency preferred. Software validation, LabVIEW, and sterile packaging experience is a plus. Associate’s Degree is required, Bachelor’s Degree preferred. ASQ certification is preferred.

Job responsibilities include implementing improvements in quality area to improve flow and efficiency of inspection process for new and existing product (including creating and identifying new test equipment); performing process validation on new equipment and processes; providing technical guidance to Manufacturing and Quality departments; supporting lean initiatives; identifying scrap/reject reduction opportunities and implementing reduction strategies; developing/improving/standardizing inspection procedures; participating in product validations, design reviews, and regulatory audits; and leading internal/external corrective action activities.

Please email your resume and salary requirements to humanresources@synergeticsusa.com for immediate consideration.

# posted by ASQ St. Louis @ Saturday, April 26, 2008 0 comments

OVERVIEW

My client is a Fortune 500 company that is dedicated to engineering, designing and manufacturing precision bearings for leading aerospace companies in North America, Europe and the Pacific Rim. Access to advanced materials, performance testing, product development and manufacturing technologies has led to superior solutions in the development and manufacture of ball and roller bearings for the latest engines and airframes.

Employing 600 people at its non-union plant in Central NH, the company is generating revenues of approximately $100 million per annum and the parent employs 26,000 people worldwide with $4.5 billion in revenues. The company is envisioning significant growth within the global aerospace market over the next decade. This position plays a key role to chartering that path of success with the goal of identifying and resolving quality issues and the implementation of continuous improvement objectives.

POSITION DESCRIPTION

The Principal Quality Assurance Engineer is a hands-on, shop floor, continuous improvement position. Business is so up, this plant is overbooked and they need to get better at what they do. Success in this role will lead to unlimited career advancement.

Specific responsibilities include:

1. Participating in a cross functional area teams (Star Team) in the resolution of quality issues in support of team objectives including (but not limited to) on time delivery goals, past-due reduction goals, scrap reduction goals, etc.
2. Supporting Continuous Improvement activities utilizing Process Capability studies, Machine Capability studies, Gage R & R studies and other statistical problem solving tools by gathering and interpreting data.
3. Implementing Operator Certification programs within assigned areas, including assessing, training, and mentoring the operators.
4. Supervising Inspection personnel within assigned departments.
5. Utilizing 8D techniques to investigate root cause analysis and perform effective positive corrective action.
6. Leading Lean Six Sigma teams, Kaizen events, and other progressive efforts.

CANDIDATE QUALIFICATION CRITERIA

Education/Certification
BSME or some other suitable technical discipline is required.
American Society of Quality – Certified Quality Engineer designation preferred.

Experience

1. 5+ years of experience within a Quality discipline is required, preferably within precision metal fabrication.
2. Possessive of comprehensive working knowledge of an ISO 9001-2000 Quality Management System, AS 9100 requirements, SPC systems, metrology, and failure root cause analysis/corrective action.
3. Possessive of strong experience with the practical applications of Lean Manufacturing/Continuous Improvement methodologies (i.e., Six Sigma, Kaizen, Set-up reduction, waste reduction, etc.) and techniques ( i.e., Poke Yoke, Demand Flow, Pull systems, 5s)
4. Having a working knowledge of product inspection methods and techniques including hand-held gauging and other special gauging measurement techniques
5. Prior experience in bearings manufacturing, the design of tooling or gauging, and with hands-on inspection are all preferred, although not required

Personal Characteristics and Traits

1. An effective communicator, both externally with clients/suppliers and internally with peers and supervisors; able to communicate on a technical level with shop floor and production personnel as well as others within the organization.
2. Someone who is passionate about quality, able to strongly defend his/her position yet open to other viewpoints
3. Possessive of a strong professional demeanor, founded upon integrity and honesty
   
4. Having a high energy level with a strong work ethic.

Compensation

Base salary dependent upon experience; additional compensation includes incentive bonus (potential up to 10% of base salary). Very strong benefit package. Full relocation assistance provided.

Interested Candidates Please Email your resume in a word document.

Kate Brandt - Executive Recruiter
Management Search, Inc.
111 Founders Plaza, Suite 1400
East Hartford, CT 06108
P: 860.761.3248
F: 860.291.8495
kbrandt@msi1.com
www.msi1.com

# posted by ASQ St. Louis @ Saturday, April 26, 2008 0 comments

Company Profile:

Spectranetics Corporation engages in the development, manufacture, marketing, and distribution of single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in the United States, Europe and Japan. Spectranetics Corporation was founded in 1984 and is based in Colorado Springs, Colorado.

Job Summary:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet requirements established by Spectranetics, customers and regulatory agencies. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development.
Maintains Risk Management documentation and provides Quality Engineering support for the life cycle of all Spectranetics products.

Education/Preferred Experience:

• BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline.
• Strong and solid experience in Risk Management for medical devices
• Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (including verification)
• Experience with Health Hazard Analysis
• Familiarity with ISO 14971
• Medical devices engineering

Job Duties:

• Provide QA leadership to project and system for the fill lifecycle of the product, service or system
• Develop, update and maintain SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system
• Ensure Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, ect.
• Lead and support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.

Pleas submit resume to: julianne.mashke@spectranetics.com

# posted by ASQ St. Louis @ Monday, April 07, 2008 0 comments