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Job Description SummaryProvide management oversite for the Mannford OK Operation. Position is the management representative for the quality management system. Management responsibilities include Compliance to regulations, management of Quality Engineering, Quality Control, Doc Management. Collaborates with Mannford leadership teamJob DescriptionSUMMARY:The Associate is responsible for strategic oversight and leadership direction within the Production QA function to include: In-Coming Inspection of all raw materials, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology while maintaining full compliance with FDA Quality System Regulations (21 CFR Part 820), all applicable International Standards (i.e. ISO 13485, MHRA GMPs, etc.) and BD policies/procedures.Associate provides business, technical, and production support, as required; provides technical guidance to employees, as required; develops processes and procedures; has in-depth Quality Assurance expertise.DUTIES AND RESPONSIBILITIES:
Delegated as the Management Representative for the site;
Responsible for the effective implementation and monitoring of the QMS to assure the suitability and effectiveness to meet quality and business objectives.
Responsible for strategic oversight and leadership direction of In-Coming Inspection, In-Process Inspection, Finished Goods Inspection, Final Product Release, Quality Engineering, Customer Complaint Investigation, Supplier Quality and Calibration/Metrology
Knowledge of FDA regulatory requirements (QSRs – 21 CFR Part 820)
Knowledge of International regulatory requirements (ISO 13845, MHRA GMPs, etc.)
Responsible for Production and Process Controls from a Quality perspective
Serves as a technical resource for all QA activities;
Demonstrates the ability to effectively apply problem solving tools.
Ability to analyze complex data and identify business implications.
Identifies data requirements, often beyond the standard, and collects all relevant data needed to analyze a complex problem, situation or issue
Advises others on a variety of topics within own functional area
Tracks internal trends and suggests process improvements based on observations
Leverages the appropriate resources to provide solutions for internal/external customers
Applies hypotheses and an understanding of cause and effect when analyzing a complex process, situation or issue or discerning data patterns
Identifies implications/conclusions from the logical analysis of a complex situation or issue
Serves as the QA subject matter expert (SME) for internal/external regulatory compliance audits
Drives team to achieve established goals in proactive and pragmatic manner; adjusts plan of action accordingly to maneuver obstacles and achieve success
Manages budget for own area, allocates resources and delegates accordingly, applying knowledge of profit drivers within own area / department
EDUCATION/CERTIFICATION:
Bachelor of Science degree in an engineering or related field.
EXPERIENCE:
Minimum of 5-7 years of experience in Quality, Engineering, and/or Management in a medical device and/or pharmaceutical environment.
Experience in interface with Domestic and Foreign government agencies
PHYSICAL DEMANDS:
Must be able to lift, push/pull, and carry up to 25 pounds
Must be able to wear appropriate personal protective equipment as required
Position requires sitting or standing for long hours
Use of hands and fingers to manipulate office and calibration equipment is required
COMPUTER & OTHER SKILLS:
Computer proficiency in Microsoft Office (Word, Excel, Power Point, Project, and Outlook)
Primary Work LocationUSA OK - MannfordAdditional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
