Job Description
Position: Director, Quality Control
Location: Mid Atlantic
Reports to: Sr. VP, Quality
Function Direct the QC department that is responsible for the assurance that all raw materials, in process materials and final products are compliant to specifications. Responsibilities include reagent raw materials, purchased chemicals, purchased disposable material, in process reagents production and final products. .
Scope: The Quality Control department is responsible for the release of over $150MM in product annually. Department is leader in reducing scrap by over $3MM. The Director is responsible for oversight of 50 people and has directly responsible for an annual budget of $3MM. This position directly affects the efficiency and effectiveness, and hence, the profitability of the overall business.
Essential Responsibilities: · Direct the activities of the final QC department · Ensure all products are tested within lead times and correct results are obtained · Lead the process to improve the efficiency of quality control activities. · Actively communicate information to other department heads so that the data can be used to reduce backorders and lot loss. · Reduce QC costs as a percentage of cost of goods sold year to year. · Take a leadership role in reducing scrap, rework and overall non-quality costs. · Improve QCWS data processing. Ensure that data runs efficiently and correctly and that platforms remain viable. · Ensure that all QC activities are validated and 21 CFR11 compliant.
Span of Control: The Director QC manages 10 direct reports and a total department of 50 people.
Requirements: · A science oriented BA/BS degree · At least 10 years experience and training in Quality Control for a medical device company is a must. · Minimum of five years in a QC leadership position. · Strong background in data and failure analysis. · Training in quality systems such as Six Sigma, TQM or other quality process is required.
Desired Skills: · Strong analytical, problem solving and modeling skills. · Excellent communication and organizational skills combined with a disciplined documentation approach and a proven ability to excel in a team environment. · Ability to write routine reports and correspondence and to speak effectively.. · Technical skills shall include: MS-Visio, MS-Excel, MS- PowerPoint, MS-Word, MiniTab, and data warehousing fundamentals.
Compensation: Competitive Salary; Performance Bonus; 401k plus a defined benefit retirement and excellent healthcare benefits
Relocation: Relocation will be provided
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