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Director, Quality in Selzach at Stryker Corporation

Date Posted: 4/17/2019

Job Snapshot

Job Description

Job Title

Director, Quality Assurance

Job String (HR Completes)

Quality Assurance. Director

Business Unit

CQR

Department Name

CQR – Clinical Affairs, Quality Assurance and Regulatory Affairs

Status

(Exempt OR Non-Exempt)

Exempt

Hours of Work

(FT, PT OR Seasonal)

FT

ERP Approval Level

A30

EEO Category

(HR Completes)

1B

Job Location

Selzach

Percent Travel

20-30%

Reports To

(Title of manager)

Vice President, Clinical, Quality Assurance & Regulatory Affairs

Manages

(Titles of direct reports)

Direct Reports:

Design Quality Assurance lead

Quality Management system lead

Risk Management lead

Education and Special Training Required

Bachelor of Science Degree. An advance degree in engineering is highly desirable.

Qualifications and Work Experience Required

•     10-15 years related experience in a quality and regulatory for medical or pharmaceutical.

•     7-10 years of supervisory/management experience recommended

•     Applied knowledge of regulatory requirements, including ISO 9001, ISO 13485, Quality System Regulation and EU Medical Device Directive and EU medical device regulation

•     Applied knowledge and demonstrated ability to effectively utilize quality tools such as FMEA, Root Cause Analysis

•     Demonstrated ability to manage complex projects

•     Demonstrated ability to manage people in a multi-discipline, multi-technology, team-based organization.

•     Demonstrated verbal, written and interpersonal skills

•     Demonstrated ability to work in a team environment and to interact effectively with management from other internal/external functions

•     Preferred candidate will have experience working in a multinational environment.

•     Fluency in English is essential; knowledge of a second European language is recommended.

•     Demonstrated success in creating a strategies to lead a team to success

•     Considerable personal experience presenting, interacting, and building effective relationships with regulatory agencies

•     Excellent communication and presentation skills (articulate and persuasive)

•     Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with medical professionals

•     Teaches and coaches others in technical and leadership areas.

Job Summary

(1-2 sentences describing overall responsibilities)

Ensure Stryker GmbH is in a state of regulatory compliance by leading the Quality organization including the division’s Design Quality Assurance Engineering function and the Quality System Management function

Essential Duties & Responsibilities

(detailed descriptions)

•        Ensure divisional achievement of quality, regulatory and compliance targets.

•        Provide a strategic direction and tactical focus to the Quality Assurance organization; manage the functional QA activities

•        Oversee effective utilization and understanding of Quality Assurance systems in our regulated environment.

•        Serve as alternate management representative in the absence of Vice President, CQR.

Work From Home: No

Travel Percentage: Up to 25%

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