R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients.

Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in.

R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer.

An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them.

“I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”

Regulatory and Quality Solutions Names Julie Maes Director of Territory Operations – Northern Lakes Region

Maes brings 25+ years of medical device regulatory, quality, and project management experience to R&Q.

Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q), a provider of industry-leading regulatory and quality engineering services to medical device and combination product companies, announced that Julie Maes has been named Director of Territory Operations for Minnesota. An industry veteran of the global healthcare and medical device industry, Maes brings extensive management and hands-on quality systems development experience to R&Q’s expanding Minnesota area operations.

In her role at R&Q, Maes will manage designated resources to guarantee the highest quality consulting and complete customer satisfaction in the region. She will also contribute to R&Q’s Center of Excellence as a subject matter expert, providing industry education on the most critical and timely regulatory and quality challenges facing our market.

R&Q Q&A: Minnesota Spotlight

Welcome to the third post in our R&Q Q&A series. Every few months we ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again that working at R&Q is a highly rewarding experience.

See current Minnesota openings at the end of this post, and view all R&Q openings on our Careers page.

Regulatory and Quality Solutions (R&Q) Certified By the Women’s Business Enterprise National Council

R&Q, provider of industry-leading regulatory and quality consulting and engineering services to medical device companies, is proud to announce national certification as a Women’s Business Enterprise by the Women's Business Enterprise Council-PA-DE-sNJ, a regional certifying partner of the Women’s Business Enterprise National Council (WBENC).

The designation signals a competitive advantage for R&Q’s FDA-experienced team of more than 80 RA/QA experts as medical device and pharmaceutical companies often look to vary their supplier base with more diversity and/or minority-owned businesses. The honor is especially meaningful to Cofounder and President, Maria Fagan, and has been a long time in the making...

Headway in PA: Announcing Dedicated Operations Directors in Pittsburgh and Philadelphia

In 2016 R&Q expanded its activities and the amount of clients served in the northeast (specifically, the greater Boston region), formally launched R&Q in Minnesota, and continued to service new and existing clients throughout the state of Ohio. In 2017 we plan to strengthen our capabilities in those areas and others by hiring some of the most qualified regulatory and quality professionals in the industry (who also are a cultural fit for R&Q). But with that said, we'll never, ever lose sight of where we started and ultimately call home: Pennsylvania.

R&Q has hired - or rather, promoted from within - dedicated operations directors in Pittsburgh and Philadelphia. Each director is tasked with ensuring R&Q is represented in the territory through:

  • Serving medical device clients and helping them thrive
  • Engaging in regional marketing/networking initiatives
  • Ensuring the growth of ongoing sales
Read on to learn more about R&Q's Jon Gimbel and Matt Burger.

R&Q Q&A: Northeast Employee Spotlight and Openings

Welcome to the second post in our R&Q Q&A series. Every few months we ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again, that working at R&Q is a highly rewarding experience. In June, we talked to two key members of the Boston team - view their responses here.

See current northeastern openings at the end of this post, and view all R&Q openings on our Careers page.

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark!

Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis!

Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.

R&Q Q&A: Boston Employee Spotlight

Welcome to the first post in our R&Q Q&A series. Every two months we'll ask R&Q employees from a different region questions about how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's corporate culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim working at R&Q is a highly rewarding experience.

Visit our Careers page to view current openings.

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.

We Made a Video About R&Q! Here's Why.

One of R&Q's priorities in 2015 was to find new, distinctive ways to tell our story. We wanted to make it abundantly clear to potential clients and employees that R&Q is first and foremost about improving lives. We also wanted to clearly explain how we improve lives.

The result of our brainstorming was to create a short video that takes the viewer through the journey of how R&Q helps our clients - from start to finish.

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