Operations and Supply Chain Medical Device RA/QA Consulting Manager
Plante Moran - Southfield, MI

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Development, Operations and Supply Chain Management Medical Device Consulting Manager (RA/QA)

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WARNING: Be sure to read through the following in its entirety. After all, this is only your career you’re working with. We don’t play around with something as fragile as this.

Finally, a place where you can safely invest in your career …

For 15 consecutive years, Plante & Moran has been recognized as one of the nation’s “100 Best Companies To Work For” by FORTUNE magazine — providing unsurpassed opportunity and an unequaled culture to talented, self-motivated individuals who have a passion to serve and a hunger to thrive. It's hard to explain what makes a great firm. We think it has to do with the people, our benefits , and the overriding culture that guides them. It's a unique balance of achievement, teamwork, caring, and an unofficial " relatively jerk-free " policy. It makes us different. It makes us better. It helps us thrive.

Responsibilities

Position Summary:
Plante & Moran’s Management Consulting Operations and Supply Chain Management Services group is looking for a Consulting Manager to join their team. Plante & Moran’s Operations and Supply Chain Management consultants work with our clients to improve productivity, quality and delivery; eliminate waste on the plant floor and in “back room” operations; reduce inventory and lead time; improve the timing, quality and effectiveness of product development, commercialization and launch; identify and eliminate the root cause of problems, conform with quality standards, optimize warehousing and transportation, and measure results.

This Consulting Manager role will primarily work with clients in the medical device industry and be responsible for management of multiple quality related projects and tasks, from product inception through product launch and maintenance

Typical engagements focus on improving the following business processes:

FDA Response

Regulatory Pathway

Quality Management

Root Cause Analysis/Corrective Action/Problem Solving

Product Development, Commercialization & Launch

Manufacturing

Process Control

Customer Relationship Management & Loyalty

Lean & Continuous Improvement

The above statements are intended to describe the general nature and level of work performed by staff assigned to this classification. They are not intended to be a complete list of all responsibilities, duties and skills required of personnel so classified.

Qualifications

As a Plante & Moran Consulting Manager for the Operations and Supply Chain Management Services group, qualified candidates must possess:

EXPERIENCE and EDUCATION

7+ year’s experience in quality and regulatory affairs

7+ year’s experience in medical device quality engineering with a background in manufacturing engineering and/or process engineering.

Bachelor’s degree in Business, Engineering or related field preferred

Knowledge in FDA, QSR, MDD, and ISO requirements.

Previous consulting experience

Strong interpersonal and team building skills

Experience too include but not limited to: development of quality and operating procedures, verification of engineering tests and measurement practices for new and existing products using QA tools, administration of supplier audits, working knowledge of FDA requirements and managing FDA audits.

TRAVEL and HOURS

This is an exempt position that may require some Saturday work hours and overtime during workweek

Qualified individuals must either reside in Southfield, Michigan or be willing to relocate to Southfield, Michigan for this opportunity. No relocation funds will be provided

40-50% travel is required with this position

There’s no place like Plante & Moran.

Outsiders know Plante & Moran as the 12 th largest public accounting and business advisory firm in the nation. Insiders know us as the place where opportunity thrives. At Plante & Moran, we define “opportunity” with three simple words: Challenge , Experience , and Growth . By diligently finding ways to insert these concepts into our work, we keep staff at every level of our firm on a steady path to the top of their game and the realization of their professional and personal goals.

Inquiring Within

Why wait, when you can play a major role in developing your career!

If your background experience matches the qualifications of this position and you are interested in pursuing this career, then inquire within. You never know where the next click may take you; it could potentially lead you to the career you have always desired!

Last, but not least…

The specific statements shown in each section of this description are not intended to be all-inclusive.

They represent typical elements and criteria necessary to successfully perform the job.

We only accept electronic applications. Therefore, those who apply directly to a position and submit their resumes through our applicant tracking system will be considered.

Only candidates selected for interviews will be contacted by a staffing consultant.

Plante Moran does not accept unsolicited resumes from search firms or employment agencies. Plante Moran will not pay a fee related to unsolicited resumes received from search firms or employment agencies and the unsolicited resumes will become the property of Plante Moran. Plante Moran will not agree to any contrary terms related to unsolicited resumes. Only candidates selected for interviews will be contacted by a staffing consultant. All candidates must be legally authorized to work for any employer in the United States without sponsorship. Plante Moran is committed to a workplace that provides equal employment opportunity. In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Plante Moran will be based on merit, qualifications, and abilities. Plante Moran does not discriminate in employment opportunities or practices on the basis of race, color, religion, gender, national origin, age, disability, gender identity, sexual orientation, genetic information, or any other characteristic protected by applicable law.

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Plante Moran (www.plantemoran.com) is the nation's 13th largest certified public accounting and business advisory firm, providing clients...