| Experience |
- Minimum of 5 years Quality and Regulatory experience in the medical device industry with thorough understanding of CGMP, CGLP, and device regulations.
- Strong understanding of current global, specifically, US and EU regulations related to Medical Devices
- Excellent knowledgeable experience of global Quality Systems Regulations, specifically in21 CFR, Part 820 and ISO 13485-2003
Familiarity with Statistical Techniques and Analysis methods and software (Minitab preferred)
- Thorough knowledge of the company's manufacturing and production processes.
- Ability to see long-term organizational mission with ability to motivate others with same vision
- Resourcefulness to determine “how to get there.”
- Team player on departmental and management team levels.including ability to present top-level presentations.
- Supply chain management experience preferred.
- Proven negotiation and facilitation skills;
- Project Management Skills
- Excellent oral and written communication skills
Strong interpersonal skills
- Action oriented and commitment
- demonstrates high degree of accomplishing tasks & delivering goals
- Ability to effectively communicate goals and responsibilities to contract manufacturing facility
- Manage vendor relationships and performance along with overall corporate logistics
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| Description |
CleveX, Inc., a medical device company which specializes in the developement of innovative skin biopsy, closure and repair solutions for use in primary care, family, OB/GYN and dermatology physician practices is looking for Sr Quality Assurance Manager.
Qualifications:
- Required: 70% medical device industry medical device quality assurance / FDA regulatory
- Preferred: 30% Supply Chain
FUNCTION:
- Manage implementation and oversight of manufacturing, distribution sourcing, procurement, and quality control compliance of CleveX products with contract vendors.
- Responsible that all products, components and related specifications are in compliance with all manufacturing and FDA regulatory requirements and guidelines.
- Responsible for development and management implementation of required regulatory processes and records to assure compliance with FDA, GMP and medical device guidance regulations.
- Responsible for vendor development, sourcing, contract pricing, production scheduling, and forecasting.
- Responsible for communicating and interacting with the FDA, Notified Bodies, and Competent Authorities for maintaining and managing the Device Registrations, Compliance Inspections, Remediation, Field Actions, MDR and Vigilance Reporting processes
- Develop and manage Quality System Policies, Procedures and Documentation
- Coordinate Customer Complaint activities including investigations, trending, CAPA’s and reporting
- Manage sourcing activities including maintenance and development of supplier relationships, contracts, agreements and quotes
- Approval and Auditing of external vendors and suppliers for cGLP and cGMP compliance
- Support suppliers with difficult manufacturing problems (e.g. yield and quality improvement)
- Establish, implement, and monitor methods and measures to ensure quality and low cost
- Registration of new and changes to current devices with the emphasis on US (510Ks) and CE Mark process
- Testing and validation of parts and protocols to assist CM
- Lead Risk Analysis/ FMEA activity
- Travel to suppliers, customers and other related activities as needed
- Identify costs improvements in manufacturing processes, components and related activities to produce and distribute the company’s product.
- Assist in research and development efforts to make changes to existing products to create a new product.
- Responsible for the following types of product information: Product availability and costs / Historical and current production trend analysis / FDA regulatory compliance audits
- Assist in the development and coordination of strategies to implement product manufacturing process improvements.
- Implement the approved plans and strategies for new products, coordinating the following activities for introduction to the market: Design and production development / Cost analyses and manufacturability
- Develop and implement the company's overall marketing strategies to achieve overall profitability, in close coordination with marketing.
- Assume other activities and responsibilities from time to time as directed.
Regulatory and Quality Systems - Required
- Regulatory ISO/ FDA compliance for product, written materials, sales training
- Market and FDA Registration / Certifications
- FDA Regulatory / Compliance, Audits and Inspections / QA system/files/documentation
- Customer complaints/ feedback/inquiries CAPA history and disposition
- Product returns/quarantined inventory
- Sterilization process controls
Manufacturing/Supply Chain/Sales Management & Support – Preferred
- Manufacturing Schedules and Coordination of Sales – Marketing Forecasts
- Supplier relationship /contacts/ agreements/quotes
- Vendor Qualification and audits
- Product Certifications
- Production plans /processes with contract manufacturers
- Materials controls /sourcing / Inventory Management
- Budget Management and Proper Costs Allocations
- Sales & Marketing Support
Qualified candiates should send their resumes to kvedder@clevex.com
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