DUAINE R. MINKE

(***) *** - **** ac4afz@r.postjobfree.com

SUMMARY

Dynamic, hands-on, multitasked executive with proven track record in Business Management, Operations, Regulatory and Quality. Demonstrated expertise handling cross-functional teams in strategic planning, organizational development, team building and staff enhancement. As an agent of change, extremely focused on identifying competent solutions. Able to effectively coordinate production, while maintaining company priorities and achieving goals. Experienced in the implementation of 5S, Lean / Six Sigma initiatives (certified). Excellent communication, negotiation and motivation skills. Fluent in English and Spanish.

EDUCATION

Bachelor in Science, Agronomy; Chemistry Minor

PROFESSIONAL EXPERIENCE

ORCHID ORTHOPEDICS SOLUTIONS 2016 – 2017

Quality and Regulatory Compliance Manager / Management Representative

v Maintained and implemented compliance to 21 CFR, ISO13485:2016 Quality Management System (QMS) and other relevant regulations and standards (European MDR, ISO 14971:2012, JPAL and Others).

Achieved quality assurance operational objectives by serving as the appointed management representative and developing and monitoring appropriate site-specific quality metrics to enhance compliance requirements and meet company objectives.

Experienced in Deviation /CAPA management. Initiated, authored, conducted Quality process assessments (RCA), remediated process issues, implemented correction, established preventive measures for acceptance and closure of deviations /CAPAs Reviewed, created and coordinated process validations and projects as well as the Validation Master Plan.

Contributed information and analysis to strategic plans and reviews; preparing and completing action plans; implementing appropriate countermeasures for KPI’s, identifying and problem solving; completing audits; determining system improvements; implementing change. Drove risk management throughout processes.

Added customer value through developing procedures and providing leadership to cross functional teams, utilized problem solving tools for resolution, PDCA, statistical analysis to reduce variation, built in quality, etc. Implemented initiatives governing the medical device industry related to design controls and risk management programs

Coordinated the effective utilization of skills, labor hours and materials to assure on time production and quality standard adherence. Worked closely with materials buyer/ planners to ensure proper net requirements level load planning and manpower staffing to support customer requirements, resulting cost reductions, work simplification, production scheduling, labor planning, and process improvement. Responsible for Supplier Management.

Hosted and supported all regulatory agency inspections and enquiries for multiple facilities. Internal / External Lead auditor.

Implemented and maintained sterilization programs for products, including pre & post sterilization procedures, documentation, review of results and release to inventory or direct shipment.

SANDVIK PALM COAST 2010 - 2015

Quality, Environmental, Health & Safety Manager / Management Representative

v Guide, promote & maintain the company’s values, strategy and long term objectives, ensuring that all activities are compliant to Quality Policy, achieving goals and objectives. Lead auditor for Internal, Supplier & Corporate Audits.

v Developed, maintained and sustained Company’s Quality, Environmental, Health and Safety compliance for three facilities, including cleanroom environment. Managed internal & external QEHS agency visits.

v Responsible for all Medical Device & Process Validations. Quality & Regulatory Agreements approval. CAPA Program Owner: RCA investigation, correction /improvement, prevention, effectiveness measurement and closure.

Responsible MRB for disposition of internal and external nonconforming product, including Suppliers.

v Coordinate, participate and precede Internal / External audits / inspections by regulatory, customers and other agencies assuring compliance with established requirements. Created FMEA for process & product.

Managed the Document Control System and Return Material Authorization Handling program. Responsible for the performance of 3 quality direct reports.

v Implemented initiatives governing the medical device industry related to design controls and risk management programs. Responsible recruiting personnel, training and performance reviews and appraisals.

v Conducted Management Reviews for Quality and EHS Systems. Presented monthly Corporate reports.

Maintained and implemented compliance to 21 CFR, ISO13485 Quality Management System (QMS) and other relevant regulations and standards (European MDR, ISO 14971:2012).

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v Identify and assist with continuous improvement opportunities for business development, optimization of medical products by using statistical control tools, developing SOP’s / specifications and providing technical transfer / validation support for domestic and international markets.

COMMAND MEDICAL PRODUCTS 2008 - 2010

Corporate Regulatory Affairs & Quality Assurance Manager/ EHSO / Management Representative

Responsible for regulatory functions including gathering and summarizing of documentation for domestic and international agency submissions 510(k) and PMA’s, compliance with regulatory requirements and standards, and ensuring customer requirements are met for Domestic and International facilities Implemented initiatives governing the medical device industry related to design controls and risk management programs. ISO 13485, 21 CFR, etc.

Effectively identified & managed hazards in the workplace, assessed those risks to Employee health and safety, any hazards that pose a threat to the work environment including damage to property.

Implemented initiatives governing the medical device industry related to design controls and risk management programs. Coordinated process SPC efforts. Responsible for 17 quality direct & indirect reports.

Directed activities of Quality Assurance personnel including material / components, product environmental assessments and quality system document control (Document Control Services). Managed MRB program.

Maintained an effective internal quality system audit program and facilitated, as Quality Representative, all external audit activity (FDA, ISO, Governmental Agencies, Third Party and / or Customers).

Managed CAPA program including: initiation, investigation review and response to quality incidents from customers, suppliers and internal processes trending quality-related performance in each of these areas.

Developed and met annual operating budgets for Quality departments and provided recommendations for capital equipment purchases (test and measurement). Performed Management Reviews.

Implemented and maintained sterilization programs for products, including pre & post sterilization procedures, documentation, review of results and release to inventory or direct shipment.

Conducted Management Reviews for Quality and EHS Systems. Created monthly Corporate reports.

INTEGRA NEUROSCIENCES PR. INC. 2006 - 2008

Sr. Manager, Quality Systems Compliance & Regulatory Affairs Support / Management Rep.

Regulatory and Quality Project leader for a $20million combination product and technology transfer, in addition to a successful FDA submission, implementation and approval. Implemented initiatives governing the medical device industry related to design controls and risk management programs.

Reviewed and approved all Engineering Changes and validations for regulatory impact for FDA, Notified Body in the EU, Canada, and Japan. Responsible Lyophilization Process & Technology transfer. Maintained a strategic regulatory business plan for all projected product & technology transfers.

Responsible for regulatory functions including gathering and summarizing of documentation for domestic and international agency submissions 510(k) and PMA’s, compliance with regulatory requirements and standards, and ensuring customer requirements are met. Represent company to all audits and visits.

Maintained current status of FDA submissions and CE Mark dossiers and technical files for FDA on new or substantially changed products. Evaluated & accepted on ETO and Gamma radiation sterilization.

Managed the Internal Audit program in Compliance with QSR, ISO 13485:2003, MDD and CMDR requirements. In charge of calibration & environmental program, complaints system, CAPA investigation, field actions, returned goods, adverse event reporting, risk & hazard assessment and other continuous improvement initiatives.

Experience in GLP, microbiological principles and aseptic cleaning validations.

SURGICAL SPECIALTIES PR. INC. 2002 - 2006

Regulatory Affairs / Quality Assurance Manager I Management Representative

Hands on project leader on product and technology transfer, ensuring smooth operations relocation.

Responsible for assuring the quality and regulatory system is established, implemented and maintained.

v Management representative to notified body, regulatory agencies and customers.

Managed Return Goods, Complaints, Customer Services, Product Release, Document Control, Internal Audit, Corrective Preventive Actions (initiation, investigation, correction, prevention, effectiveness & closure).

Adverse Event Reporting (MDR), Calibration and Environmental Programs in Compliance with QSR, ISO 13485, MDD and CMDR requirements.

Evaluated and accepted criteria for Ethylene Oxide (ETO) and Cobalt 60 Gamma radiation sterilization.

Supported corporate Product Development process as related to regulatory inputs and decisions.

Provided support and consulting in product and technology improvement to companies such as: Inter V, Intuitive Surgical, Mannan Medical, Gyrus ENT, J&J, Bard, Hu Friedy and Others.

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Directed cross-functional teams in product and technology applications. Prepared departmental and support services budgets. Responsible for 21 quality direct reports. Head of the Material Review Board (MRB).

Managed under corporate RA risk assessment and hazard evaluations.

Coordinated, facilitated, directed and created documentation initiatives to streamline operations locally and at other sites.

JOHNSON & JOHNSON CORP. / Cordis 2000 - 2001

Senior Operations Supervisor / Shift Manager

Planned, organized and guided assigned work teams in their performance of the overall manufacturing process on assigned programs. Supported and delineated SPC program strategies.

Monitored and trained 48 associates while insuring compliance with standards, policies and regulations for the production of neurovascular and cardiovascular micro catheters.

Cross-trained associates in multi task processes, which increased shift production yields by 33% for the year 2000 fourth quarter. ETO and Gamma radiation sterilization exposure. Coordinated process & product validation efforts.

Recruited and developed personnel that increased shift head count by 50%.

Developed a daily production awareness program, which encouraged associate participation and increased productivity by 11%.

Develop and implement strategies to leverage other resources to streamline External Manufacturing processes, standardize practices and eliminate non-value added work.

Participated in Black Belt project improvement teams, which minimized scrap by 40%. Certified Lean Six Sigma Green Belt, leading production projects locally and in Mexico.

Overview of change control meetings and responsible for approval of deliverables in an appropriate timeframe.

Confer Nonconformance investigations, Verifying Implementation of Change Controls, Manufacturing/ Packaging Directions, Stability Management, Product Reviews, Performance and Business Matrix. Proposed safety and security changes that promoted effective and prompt response to areas in need.

Led CAPA program: issued, initiated, investigated, corrected, prevented, measured effectiveness and closure

BRISTOL MYERS-SQUIBB CO. 1997 - 2000

Sr. Quality Assurance Supervisor

Managed customer claims/ complaints and CAPA investigations while coordinating the evaluation and reporting all manufacturing facilities’ quality incident and deviation investigations for oncological, Parentherals and oral solid / liquid/ powder steroid I non-steroid products.

Supervised of 12 Quality Assurance Inspectors on a 24 hr. / seven day a week operation.

Coordinated the Batch Record review process for a group of 14 reviewers per cGMP guidelines.

Lead, participate and guide quality & regulatory compliance customer and agency audits.

Develop team strategies (cross-functional); provide effective communication modeling the “lead by example” approach.

Led “continuous improvement” cross-functional teams with excellent results. MH / Steam sterilization exposure.

Improved operational efficiency by creating new departmental procedures and recommending revision of procedures for various departments. Created process and equipment validations.

Conducted operations meetings that minimized “lots on hold” release from twelve to four days, reducing stock inventory by 50%, increasing consumer satisfaction to 98%.

BAXTER HEALTHCARE CORP. 1994 - 1997

Manufacturing Superintendent

Implemented company strategies to meet aggressive EHS, Quality and Production goals, demonstrating compromise towards continued improvement throughout empowerment and teamwork. Evaluated personnel & facility EHS risks. Responsible for hazardous material identification & handling.

Proposed and implemented procedure changes to streamline the assembly, packaging and testing process per established QSR, ISO, MDD and CMDR requirements.

Managed all new product and technology transfers. In charge of pilot runs in addition to validation protocols.

Manage cross-functional teams in the successful transfer of new products and technology from the United States to Puerto Rico and Dominican Republic facilities in a timely and cost effective manner.

Prepared documented protocols for processes, which were consistently qualified, validated and implemented. ETO, E-Beam and Gamma radiation sterilization exposure. CAPA owner: wrote effective measures to address deviations / nonconformance

Delineated and managed department’s budget effectively reducing cost and scraps accounts by 13% for 6 months.

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