Regulatory Job 559474-Design Control Manager

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559474-Design Control Manager WI 30 - 100k (J#13318)
Education: Bachelors Degree
Experience: 4 - 9 years

Essential Functions (Responsibilities):
There are currently 4 Design Control Managers open in Milwaukee, WI

Provide guidance to product development teams as to the required deliverables to ensure compliance throughout product development cycle.
Review, assess and approve product design milestones and deliverables throughout product development cycle to ensure compliance.
Assist engineering/operational quality/compliance representatives to identify compliance risks during the product development cycle.
Proactively assess risk, plan and execute audit deliverables.
Communicate audit results and recommendations to senior management. Create and drive business wide improvement efforts to improve systemic challenges.
Interface with Senior Management and partners during inspections, audits, investigations and report-outs as necessary.
Educate and train engineering/operational quality/compliance representatives to ensure adoption of design control best practices.

Qualifications/Requirements:
1. Bachelor's in engineering (or high school diploma/GED plus 4 years working experience and understanding of product development, manufacturing, quality control and servicing in a medical device environment)
2. Minimum 5 years experience in Quality or Engineering
3. Expertise: Subject Matter Expert (SME) in product design and design controls.
4 Demonstrated experience in a regulated business.
5. Must submit application for employment through gecareers.com (or COS if internal) to be considered
6. Must be 18 years of age or older
7. Must be willing to take a drug test as part of the selection process
8. Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background.
Desired:
1. Previous auditing experience (i.e. GAC, CAS, FDA, ISO, etc.)
2. Strong knowledge of Quality Systems policies and regulations (ISO, GxP, FDA, and other key regulatory bodies) & strong background in medical device Quality Assurance & processes
3. Possesses strong understanding of the new product introduction (NPI) process
4. Ability to directly interface with governmental & independent auditors & external agencies as well as top organizational leadership successfully
5. Demonstrated experience working with Local and International Regulatory Agencies
6. Able to effectively analyze complex quality system requirements & handle multiple tasks with competing priorities
7. Ability to seek & drive alternative solutions/approaches when required
8. Strong business acumen-understands key financial metrics, understands business trends & cycles & is able to influence key business strategies & initiatives, demonstrates knowledge of key business measurements (i.e., market, products/services, suppliers, competition, performance measures) & is able to link Quality Assurance strategy to this framework.
9. Responsive, reacts with appropriate urgency & professionalism
10. Change agent with energy, passion & skill to drive change
11. Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation)
12. Demonstrated ability to effectively balance/prioritize issues
13. Analytical/problem solving/root-cause analysis skills
14. Effective judgment & decision making skills
15. Strong relationship building/networking/interpersonal skills
16. Excellent communication skills (written & oral)
17. Integrity: Adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others

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