Engineer Manager

ERIC E. ANDERSEN

** ****** **** - ******, ** ****1 - 302-***-****

email: ************@*******.***

SKILL SUMMARY

Experienced professional with 25+ years in FDA regulated Medical Device

industry. Proficient in Design Controls (led 4 Design Control projects

from start to finish including 2 new product introductions), validation

activities (typically wrote, organized and executed 1 validation /quarter),

and material selection / qualification (implemented 2 new major resins and

8 new silicone solutions). Updated or wrote procedures in support of

changes. Provided training.

EXPERIENCE

CONSTAR, INC, HAVRE DE GRACE, MD

Manufacturer of Performs and Bottles for carbonated soft drink, water, and

other markets.

Nov 2009 - Sep 2010 Quality Manager

Quality Manager: Responsible for customer contact on quality matters

including returns coordination, authorization of credit for defectives,

generation and distribution of Root Cause - Corrective Actions plans. Also

managed internal inventory of defectives.

. Provided training in defect recognition

. Communicated Quality metrics: heldware generated and released, complaints

received and closed, claims received

. Provided technical liaison to plant for new instrumentation and gauging

devices

. Provided customer visitation for onsite review of issues.

TERUMO MEDICAL CORPORATION, ELKTON, MD

Manufacturer of Insulin and Standard Syringes, Hypodermic Needles, Fistula

Needles, Catheters and other Medical Devices

Nov 1999 - July 2009 Senior Technical Engineer

Senior Technical Engineer: Responsible for "Cradle to Grave"

implementation of various cost saving initiatives, material substitutions,

new product introductions, specialized troubleshooting, act on behalf of

department manager.

. Material substitutions: molding resins and colorants - Successful

implementations prevented line stoppages or plant shutdown

. Solvent substitutions: Heptane replaced HCFC 141b - An environmentally

motivated change, saved the factory $300K annually,

. New product development: Blood Collection tube, 31G Insulin Syringe,

Interventional sheaths. Identified and qualified new production materials

and processes. Performed Design Control activities and maintained Design

History Files,

. Troubleshooting: Syringe flange breakage, locking tooth failure in

Surguard 2 product line,

. Authored, executed, and brought process validations (IQ, OQ, PQ) to

closure.

Nov 1998 - Nov 1999 Injection Molding Department Manager

Departmental responsibility: Responsible for schedule attainment, cost

containment, component product quality, long range capacity planning,

personnel issues and relevant regulatory compliance.

Aug 1996 - Nov 1998 QA Engineer; Senior QA Engineer

Senior Quality Engineer: Responsible for responding to consumer complaints,

developing and maintaining quality standards, establishing control systems,

recommending and monitoring effectiveness of corrective action. Approve

Quality Bulletins, deviations and Validation protocols. As Senior QA

Engineer, supervise 2 QA Engineers and periodically act as QA Manager.

. Reviewed specifications for inspection of plastic parts, investigated

defect criteria, and changed those specifications to more accurately

reflect the needs of the consumer and capability of the process. Resolved

Assembly problems relating to IM quality. Developed network Computer Based

Training for defect recognition.

. Developed Injection Molding Process Validation strategy.

. Select, justify and acquire capital equipment for laboratory. Purchased

Tinius-Olsen tensile tester, analytical balance.

PLAYTEX PRODUCTS, INC., DOVER, DE

Manufacturer of Tampons and Rubber Gloves - Distributor of Infant care,

Hair care and Skin care products

1983 - 1996 Senior QA Engineer; QA Superintendent; QA Manager,

Manufacturing

EDUCATION

MBA, Wilmington University, Wilmington, DE

BS Mathematics, Carnegie-Mellon University, Pittsburgh, PA

OTHER AWARDS

Certified Quality Engineer; Certified Quality Manager

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