Many contract manufacturers promise a “Concept to Commercialization” solution to the Med Device space but few actually deliver on that promise the way this CM does. Worldwide locations offer their clients a deep well of potential solutions while offering qualified candidates an exceptional prospect for personal growth. An extraordinary array of machining, molding, assembly and cleanroom capabilities means the client realizes a complete product from multiple sites using a common QS; for the person qualified for this role it means daily challenge filled with the variation of the service offering.
No, we aren’t looking for someone ready to sit back and watch their world go by as the daily requirements for Quality are “met”. We’re looking for the kind of Quality people that have been frustrated by being pigeonholed into roles that don’t allow them to make a difference; who aren’t able to see the fruits of their efforts really impact the success of the organization. We’re looking for people with Process Control & Capability, Systems, IQ/OQ/PQ, V&V, SPC, and a passion for Quality that transcends the system to create a culture.
We are seeking quality experience in Manufacturing Process and Development Assurance and have opportunities in multiple locations including IL, PA, MA, MO, MD and NH.
- Ensure compliance to ISO and other regulatory bodies (e.g. FDA) including internal training; periodically assessing compliance of process to ensure safe and effective products
- Apply techniques like DOE, DFM(A), FMEA and SPC to product development and existing products, achieving maximum quality levels and COGS control
- Provide for timely completion of any and all documentation required by the QS, meeting the needs of the client’s systems and verifying compliance to regulations
- Actively participate in IQ/OQ/PQ, writing and reviewing protocols and reports to assist in V&V activities of production processes
- Conduct Process Capability studies for the purpose of confirming acceptable results for new products and/or Process Improvement of existing products; in the latter instance ensuring that required documentation is provided to the client and/or internal Change Notifications
- As required, investigate Customer Complaints performing in-depth Root Cause Analysis and leading problem-solving efforts to resolve sporadic and chronic quality issues in a timely fashion and compliant to regulations
- Actively participate in the development and achievement of Continuous Improvement plans
- May independently inspect components and finished goods for compliance to specifications
- BS in Engineering or related field
- QE/3-5 years’ experience; Sr. QE/5+ years
- Experience in Customer Focused Quality and/or Business Process Improvement
- Knowledge of FDA QSR, ISO13485 and ISO14971 Risk Assessment
- Experience in medical devices or Regulatory/FDA or ISO manufacturing setting
- Internal/External Auditing experience