Quality Director Resume Raleigh, NC - Hire IT People

SUMMARY:

Approximately 15 years in the medical device field as an Engineer and Manager in Quality and Regulatory roles. I have focused on both production and Confidential, and I have worked in both FT and contract/consulting positions. I have experience in both small and large companies and am looking for a new opportunity in the industry. I am open to either contract roles or the right direct hire role.

PROFESSIONAL EXPERIENCE:

Confidential, Raleigh, NC

Quality Director

Responsibilities:

Created Complete Quality Systems for 4 companies essentially from scratch:
Importer/Distributor, Contract Manufacturer, Design & Manufactures.
Written for both Electronic and Paper Systems.
Very Good External Audit Defense Record (QSIT, For Cause, ISO).
Written to Comply with 21CFR, ISO 13485, ISO 14971. ISO Certifications Achieved.
Supported Quality Systems I have created and also several others I have worked under:
Hosted a dozen+ FDA/ISO audits as Management Representative (most resulting in no findings).
Achieved and Maintained ISO 13485 Certification.
Participated in dozens of Audits as SME, Front/Backroom Lead, etc.
Been an integral part in remediation follow - up inspections.
Supplier Quality Manager: Audits, SCARs, NCRs, Validations for dozens of vendors.
Managed Training, Complaint, and CAPA Systems creating/overseeing hundreds of records.
QA/RA Reviewer of Documents (CO, CAPA, Complaint, Validations, DHF/Project Files, etc.)
Worked in Consent Decree Environment for years and championed remediation activities.
Firm believer in Root Cause Analysis and associated techniques and Tools.
Familiar with several QMS and CAPA software platforms (ETQ, MQ1, Agile, eMatrix, Quest, etc.)

Confidential, Ann Arbor, MI

Dir. QA/RA, Quality Manager, Engineer

Responsibilities:

Key Member in Design Inputs/Outputs, Verification & Validation, MFG Scale-Up, PMS/PMCF.
Submitter and active in 510(k) submissions, FDA & CPB correspondences.
Have successfully led projects to achieve CE Mark, and approval in dozens of other countries.
Lead for FMEA/PHA/Other Risk Management Tools and their effective implementation and use.

Confidential, Naples, FL

Dir QA/RA, Quality Manager, Mfg/Process Engineer, Production Supervisor

Responsibilities:

Validations (Process, Software, Design): Written/Executed Hundreds of protocols, plans, reports.
Hands-On with several ERP/MRB/Planning resources (JDE, Expandable, Quickbooks, SAP)
Frequent travel to and work with foreign companies.
Champion of visual factories and distribution of knowledge for good decision making.
Good Knowledge of Controlled Environments and EO Sterilization Processes.
Vast experience in Fixture Creation, Inspection Setup, NPI support, Test Method Validation.

Confidential, Ann Arbor, MI

Sr. Engineer, QE Manager, QA Manager, Dir QA/RA

Responsibilities:

12+ years of direct reports (hiring/letting go/assessing performance/coaching/personality conflicts/etc.):
Groups of 30+ Hourly Production Associates
Groups of 25+ Technical Staff
Managed folks from diverse backgrounds: 6 continents and 25+ nationalities.
Project Manager
Relocation of 7 products’ processes from Tustin, CA mfg site to Ann Arbor, MI with no impact to customer.
Accountable for project management, all assets & processes and their assimilation.
Firm believer in coaching and mentoring employees.

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Quality Director Resume

Raleigh, NC

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