Opportunity Snapshot

This position offers you the opportunity to assume ownership of broad and comprehensive quality programs at a fast growing capital equipment manufacturing company. While these programs -- covering both product and process quality -- are established and effective, you also will be able to make an impact by bringing a partnering approach and identifying ways to improve. We are committed to helping our people develop professionally, and your success in this role could set you up to pursue promotional opportunities as they arise. You'll enjoy the collaborative and entrepreneurial spirit of a smaller (but global) company.

You will plan, coordinate, and manage all QA programs and processes, from overseeing day-to-day operations of the QA team to running internal audits to contributing to new product development. To be a good fit for this opportunity you will have significant experience in QA, including managing people and programs, in a capital equipment manufacturing environment, ideally in the medical device or aerospace industries. You also will need a working familiarity with at least one of the following: ISO 9001:2000, ISO 13485:2003, or FDA Quality System Regulation (21CFR820). Formalized quality training, such as Six Sigma, is a plus.

While we are not at liberty to reveal our company name until you have been fully qualified, we are a medium sized company manufacturing unique products for intriguing applications across multiple markets. Our continued growth is driven by our strong reputation for delivering reliable, innovative, and cost effective solutions.

What Else You'll Bring to the Table

In addition to the qualifications detailed above, you'll need:

• A bachelor's degree, preferably in a science or engineering related discipline or equivalent (Mechanical Engineering would be ideal); however, we also will consider candidates with an equivalent combination of education and relevant experience.
• Knowledge of mechanical engineering concepts and applications.
• A track record of success with:
  • Establishing and maintaining an ISO or FDA system over significant time, as evidenced by smooth audits and cost savings.
  • Involvement in new product development processes.
  • Building and maintaining solid relationships with Operations and Engineering.
• A collaborative, partnering approach, but also the ability to stand your ground when necessary.

What's in It for You

Great work environment -- we promote a team oriented culture and open communication in an innovative, engineering-oriented environment. As a smaller organization we are very agile; our management is open to new and creative ideas, and the path to decision-making is short.

Autonomy and innovation -- we are a process-oriented company and you'll find a strong commitment to exploring better ways of doing things. We'll provide support when you need it and "elbow room" when you don't.

Stability and growth -- with years of success behind us, we are the leading global supplier in our niche areas. The diversity of our markets enables us to maintain constant growth.

Excellent compensation -- in addition to a competitive salary and bonus incentive program, we offer a comprehensive benefits package.

More About Your Role

If you're a good fit for this position, you already know most of what this job entails. However, to be sure we're providing a complete picture, here are some details.

You will assume leadership of a small team of direct and indirect reports in quality assurance and inspection, and you also will make hands-on contributions. For the most part, you will oversee activities in seven key areas:

• Ongoing day-to-day operations will involve overseeing the QA teams, helping resolve issues that arise, and contributing to the resolution of customer complaints.
• Product QA, including inspections, incoming materials, production processes, and finished products. All non-conforming materials are dispositioned through QA.
• Process QA, applying SPC methods not only to monitor current processes, but also to propose and evaluate process improvements.
• Quality standards and systems, including internal quality audits, corrective and preventive action, supplier quality, and training.  You'll be responsible for ensuring we remain in compliance with ISO 9001:2000, ISO 13485:2003, and FDA 21CFR820 and you'll represent us in interactions with our ISO Notified Body and the FDA.
• New product development; we design our own products, and you will be a member of the team that will plan and implement development of new products.  This will include participating in the RFP process and contract reviews.
• Quality planning and policy for the entire company, assuming the mantle of subject matter expert in QA. This will include interacting with customers and suppliers, and also representing QA on cross-functional management teams. You also will ensure proper quality training in all areas.

Keys to Success

To excel in this role you will promote solid relationships with Operations and Engineering based on an understanding that there is a grey zone between the black and white -- your mission will be to ensure that zone is narrow enough to ensure compliance and maintain our quality standards but broad enough to allow production to thrive and grow. In addition, in order to be an outstanding Quality Assurance Manager, you will:

• Achieve your goals with minimal supervision, while keeping your supervisor in the loop.
• Remain flexible but focused in our fast-paced environment.
• Keep an eye out for continuous improvement opportunities.

If this sounds like the right mix of challenge and opportunity for you, and you meet the minimum qualifications, we want to hear from you!