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Online Resumes with "Complaints MDR"



Goal focused Quality Leader in medical devices and pharmaceuticals

Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...

Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.

Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs

Experienced Quality Professional, Medical Device - Northern NJ

Seeking an opportunity in Quality Assurance or Regulatory Compliance. Small and mid-sized companies offering variety and challenge are preferred, but will consider all full-time or consulting positions in the northern NJ/southern NY area that fit my experience.

Tags for this Online Resume: Quality System Documentation, Technical Writing, Regulatroy Compliance, Complaints MDR, Audit, Gap Analysis, Mentoring, Microsoft Office