On a retained basis, Weber & Company recruits for Medical Device start-ups and Fortune 500 companies. Our clients are leaders in a broad range of product markets including orthopedics, instrumentation, cardiology, and minimally invasive surgery, as well as in-vitro diagnostics. List of current opportunities we are working on:
Executive Director Quality Assurance/Regulatory Affairs -- Retained Search
Location: Chicago, IL
Salary: $165,000 to $190,000 + bonus + relocation
Multi-national, multi-billion dollar Medical Device company seeks experienced, high-energy, results-oriented leader with a strong operational Quality background. This newly created Executive Director opportunity reporting to the SVP will own and lead the Quality/Regulatory functions at multiple sites globally for the new business, as well as drive the integration of a recently acquired Medical Device business into its parent company.
You will be responsible for leading culture change, Q&R structural reorganization as well as having the opportunity to hire a lot of new talent. Specific duties and responsibilities will include: significantly lowering compliance risk exposure; identifying and addressing potential problems in the plants; driving best practices; architecting and leading organizational development by re-setting the organization in place to grow/build the correct infrastructure; identify talent and recruit/develop talent; introduce world-class quality systems and advanced quality engineering tools in support.
Pre-market Regulatory Affairs experience is not a requirement, so taking ownership of this department may represent a tremendous growth opportunity for those seeking to round out their background for VP/SVP opportunities down the road. Your success will play a key role in the company's success in reaching its 5-year goal to increase their sales by $3 billion to $5 billion.
- Extensive experience in the Medical Device Industry is required;
- Must possess a strong leadership track record and proven management competence under difficult Quality Compliance conditions;
- A well-rounded Quality Engineering/ Quality Operations/Quality Systems knowledge as per the FDA QSR's and experience interacting directly with FDA;
- Multiple-site management experience will be of strong preference, though demonstrating the bandwidth to step up to such a role may suffice;
- Must be able to think strategically, act with accountability, bring credibility via the ability to drill down to product/ process issues and resolve them as needed, see the big picture, communicate well to the highest levels of an organization & demonstrate advancement potential to the VP level;
- B.S. Degree is required at a minimum, Engineering or Science degrees are strongly preferred.
- Qualified candidate must possess previous experience as a Quality Engineer on New Product Development teams, ideally for software-driven/electro-mechanical medical devices;
- Knowledge of good design assurance, design control, and product transfer procedures. 3-10 years experience preferred;
- Must be able to demonstrate you can thrive in a small company environment where everyone enjoys being hands-on;
- Must possess an undergraduate degree in a technical discipline, advanced degrees as always are preferred.
- FDA interaction and/or FDA remediation experience is also preferred;
- Minimum B.S. degree in an Engineering discipline is required, advanced degrees are preferred.
- Qualified candidates will possess a strong Regulatory and Quality Assurance Medical Device experience in the international marketplace;
- Portuguese and English fluency required, Spanish fluency preferred;
- Valid passport for 15% International Travel;
- Bachelor's Degree in a technical or medical based field.
Senior Design Quality Engineer
Location: San Antonio, TX Area
Salary: $82,000 to $108,000 + bonus + relocation
Emerging Medical device technology company seeks two (2) talented Design Quality Engineers -- one with a focus on software quality and another with a hardware focus. The company is striving to commercialize an exciting PMA medical device that is forecasted to change the game within the imaging technology niche. Both positions will work directly with the Vice President Quality / Regulatory on strategic initiatives towards the launch of a complex electro-mechanical medical device.
The Senior Software Quality Engineer will provide all of the Quality support of the complex software development for this Class 3, software-driven, PMA devices. The Senior Design Quality Engineer will be in support of mechanical and hardware development. Both positions will play integral roles on the design team as they prepare for product approvals and roll out to market. You will bring state-of-the-art technologies and innovations to public and get in on the ground floor of a growing and rapidly expanding company.
Director Quality Engineering - Manufacturing & Process Quality - Retained Search
Location: San Diego, CA
Salary: $155,000 to $180,000 + relocation
Dynamic multi-billion dollar Medical Diagnostics company is seeking a very technically astute Quality Director who will be ultimately responsible for ensuring a more compliant Quality System is created. This Director will work directly with Global GMs, VPs Manufacturing and VPs Quality to ensure that technical and remediation projects on both sides of the Operations/Quality fence are being executed toward creating a more streamlined and pragmatic Quality System for the organization overall.
This highly visible role will be a key driver to ensure that worldclass systems are adopted and manufacturing practices are properly re-validated. Forecasted growth of $2-3B in sales hinges on the success of this ground work.
Qualified candidates must possess extensive Quality Assurance leadership experience within the Medical Device industry, as well as a strong Quality Engineering skill set in addition to the demonstrated ability to lead, train & mentor others.
Manager Quality Assurance / Regulatory Affairs - Latin America - Retained Search
Location: Miami, FL
Salary: $105,000 to $125,000 + bonus + relocation
Our client is a large market-leading Medical Device company that is poised for tremendous growth. We have been retained bring in a strong Manager who will be the key player in working with their distributors to address safety and correct field issues in a timely manner.
This position will have its main focus on Regulatory submissions with a heavy focus on the Brazilian market. You will also lead quality system improvements and drive a good Quality Assurance Mantra with their international distributors in an effort to close the current loopholes. As a key member of the companies Latin America team you will act as the liaison between European HQ and their Latin America contacts.