SUMMARY:

• Implementing and assuring contract manufacturer Uniform Device Identification (UDI) compliance Previous 10 month contract assignment working as a Confidential Team Six - Sigma Black belt involved with closing CAPAs as part of very large remediation project.
• Confidential has held leadership positions in manufacturing QA, having supervised 4-25 people on multiple shifts and spread over multiple plant sites.
• Roles have included hands on involvement and interaction with manufacturing related functions on the shop floor.
• He has extensive experience technical writing experience with; reports, procedures, QA plans, control plans, protocols/reports, CAPAs, supplier audit reports, engineering change requests, and distributed product risk assessments.
• Confidential is well versed in SPC and has taught SPC to fellow employees, implemented SPC in manufacturing, installed automated SPC systems, conducted capability studies and design of experiments. Confidential has been a “hands-on” leader, having inspected product, conducted testing, calibrate gages, work with inspectors and production workers.
• Customer, supplier, and registrar interaction as management representative; has been a common activity in Confidential ’s work history.
• He has hosted visits, audits, and supported quoting new project opportunities internally, and visiting suppliers externally.
• He has also been a member of product/process development teams with R&D and Mfg.
• QA /validation Engineer supporting value streams and production lines.
• Experienced with developing, implementing, and maintaining quality management systems
• 20+ years of QA work experience in Manufacturing

EMPLOYMENT EXPERIENCE:

Senior Supplier QA Engineer

Confidential, MA

Responsibilities:

• Support communicating UDI requirements to contract manufacturers and answer questions.
• Assessment of contractor current compliance state to FDA UDI requirements
• Evaluate equip and labeling
• Qualify/validate new equipment and materials
• Tracking compliance status, action items, and changes.
• Secure sustaining control plans for compliance from contract manufacturers
• Process labeling/packaging changes thru change control system
• Responsible for facilitating the development and implementation of significant process improvements within the organization.
• Additional responsibility includes gathering relevant, factual information and data in order to solve quality related problems.
• Resolve issues by identifying and applying solutions from acquired Six Sigma, Lean, technical experience and guided precedents.
• Plan and lead projects by identifying and organizing activities into time dependent sequencing with realistic timelines.
• Work effectively/ productively with all departments by developing a team atmosphere.
• Responsible for tracking and reporting all project progress, successes and failures. Interacts with many different functional departments, suppliers, and experts outside Zimmer to implement Zimmer Quality goals.
• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing project plans for Continuous Improvement Projects, Facilitating and Leading Project to Closure.
• Implementation of SPC on Manufacturing Processes
• Implementation, training and overall site rollout of new data gathering software systems
• Leading Corrective and Preventative action Teams through root cause analysis
• Defining and Maintaining Quality Performance Indicators and Process Performance Metrics.

Design Assurance Engineer

Confidential, Fort Wayne, IN

Responsibilities:

• Review orthopedic product Design History files, Field Failure data, CAPAs, and risk report documentation and write distributed orthopedic product risk assessment reports in response to product failures.
• Generate CAPAs for issues requiring more investigation and action.
• Review design development projects.
• Perform other duties as requested by client.

Quality Assurance Engineer Consultant

Confidential, Gary, IN

Responsibilities:

• Lead PFMEA development teams.
• Review work instructions, control plans, statistical plans. Create managerial spread sheets.
• Validation of manual assembly process, perform gap analysis for the validations and risk analysis for product.
• Complete master PFMEA & validation plan for client producing silicone airway products/endotracheal tubes.

Quality Assurance Engineer Consultant

Confidential, Hudson, NH

Responsibilities:

• Perform risk assessments via FMEA following ISO14971 guidelines.
• Reviewing process specifications and design History files DHF
• Writing validation protocols and reports after execution.
• Propose and submit work instruction changes

Mfg. Engineer-Validation

Confidential, Minnetonka, MN

Responsibilities:

• Write Equipment specifications (ES) and Installation Qualification (IQ) Validation protocols.
• Initiate documents change requests into Windchill system
• Procure equipment for new production line, install and qualify.
• Initiate change requests.
• Revise manufacturing and inspection/test procedures.

Senior Supplier Quality Engineer

Confidential, Plymouth, MN

Responsibilities:

• Integrate acquired product line into Confidential operations and QA system.
• Perform supplier audits and qualifications.
• Write inspection plans for new parts - protocol & report
• Process & disposition nonconforming parts.
• Pursue supplier corrective actions for deficiencies.
• Qualify parts & processes - revalidation
• Process document changes.
• Maintain qualified supplier and approved parts lists.
• Visit suppliers to; resolve quality problems, review scorecard, verifying documented capable processes.

Senior Quality Engineer

Confidential, Plymouth, MN

Responsibilities:

• Responsible for QA activities in clean room manufacturing of Catheter shafts: braid, PTFE, PET, FEP, PEBAX, silicone tubing, extrusions, reflow.
• Assist with customer and regulatory visits.
• Manage and coordinate customer complaint activities - CAPAs, DOEs.
• Process development team member
• Perform risk assessment of process and implement control plans
• Work on continuous improvement projects.
• Internal auditing to QMS, GMP, ISO 13485, process plans
• Research new QA technologies
• Establish problem solving tool box for workforce
• Provide and arrange training: Confidential, problem solving tools, statistical techniques.
• Submitted 3 year plan for Lean enterprise transformation

Project Lead

Confidential, MN

Responsibilities:

• Lead laser welding & metallographic inspection components of the Nadcap accreditation process for welding & brazing.
• Work with Nadcap checklist requirements, write/revise procedures, work instructions & forms.
• Assist in coordinating efforts across departments and different business functions, training & qualification.

Supplier Quality Engineer/Consultant

Confidential, Mounds View, MN

Responsibilities:

• Developing a list of purchased components used for the development, clinical manufacturing, installation and servicing of finished devices intended for human use.
• Identifying applicable quality records to define component quality risk, including, but not limited to, outputs of: critical feature identification, failure mode and effect analysis (design, manufacturing, suppliers, etc.) component qualification and/or characterization, severity rankings and key characteristics worksheets.
• Analyzing data and information in order to define and document component quality risk per the customer’s internal procedures.
• Conduct Supplier Process Control Maturity Assessment.
• Determine supplier’s overall level of process control maturity, including completing phone interviews to assess supplier process control maturity.
• Review specs before release to suppliers,
• Perform Supplier Process Control Plan Implementation
• Guiding suppliers in the development and/or review of control plans.
• Approval of supplier control plans.
• Identifying minimum characteristics and supplier process stages to be included in supplier control plans.
• Defining and identifying any applicable processes that require a control plan.
• Identifying sub-tier suppliers that require control plans.
• Training suppliers in the customer’s internal procedures including the following: Control Plans, record retention policies, and process validation for special processes, responding to CAPAs.
• Vendor processes included: injection molding, casting, machining, raw materials, leads & cables, chemicals.

Field QA Project Specialist

Confidential

Responsibilities:

• Represent client to suppliers.
• Inspect & release product at suppliers.
• Initiate NCR & corrective actions.
• Report findings & status.
• Perform supplier assessments & process audits.

Quality Manager

Confidential, White Bear Lake, MN

Responsibilities:

• Implemented on-line IQS advance quality module, integrated ERP system.
• Manage & implement process change requests.
• Perform process validations and documentation
• Supervised 6 personnel, trained, delegated and completed performance reviews
• Revised quality system, defined and improved processes, and instituted process auditing.
• Assure customer compliance
• Respond to customer nonconformances and Confidential .
• Ensure practices are consistent with QA policy and regulations.
• Mentor and train others.

Assistant Quality Manager

Confidential, St. Paul, MN

Responsibilities:

• Implemented quality plans on construction projects, and verified plan implementation.
• Managed ASME B31.1 & B31.3 & B&PV code QA system.
• Supervised 20 field Quality Assurance personnel
• Developed on-line training for field personnel saving $15000 in travel expenses.
• Coordinated project to establish customer satisfaction measurement system.

Quality Director

Confidential, Lakeville, MN

Responsibilities:

• Lead effort to implement IS0 13485 quality system and GMP to prepare for registration.
• Lead and organize change implementation teams to define processes.
• Execute (VMP) Validation Master Plan with IQ, OQ, PQ submissions for customer approval.
• Provide support and leadership in the Quality Control/ Assurance area to promote and control ISO processes and procedures.
• Handle dept staffing and training.

Quality Assurance Manager

Confidential, Big Lake, MN

Responsibilities:

• Lead all activities within the Quality Assurance areas.
• Develop and maintain a quality system that assures that products are manufactured to customer requirements and complies with customer and industry standards.
• Supports and leads continuous improvement efforts related to processes, tools and materials for new and existing customer base.
• Work on process improvement projects and Confidential .
• Re-engineer an employee suggestion system resulting in 200% increase in suggestions
• Managed the machine tool calibration & performance assessment process resulting in reduced inspection costs and high customer confidence - early adopter of technology.
• Responsible for hiring Quality Assurance personnel and supervising multiple sites & shifts.
• Host numerous customer and regulatory visits: reviews, audits, quote.
• Hands on manager working in inspection lab, manufacturing floor, suppliers.
• Division Quality Assurance Manager (direct), Oildyne Division, Parker Hannifin, New Hope, MN 1998-2006 . (NYSE listed) (Oildyne Designs and manufactures compact fluid power systems and components for OEM, automotive, marine, and general industrial markets around the world involving machining, plating, painting, assembly, test, packaging processes, 120mil sales, 220 employees.) Left to take another position. QS-9000 & ISO-9000 QA system.
• Responsible for Division QA Function and results
• Responsible for QS-9000 (TS-16949) system implementation and registration
• Implemented ABS/IQS Quality Management System software application.
• Applied the 6 sigma process to improve customer returns, resulting in 300% faster processing and defect reduction of 40%.
• Hands on Manager working on manufacturing floor, inspection lab. Engineering, at suppliers. Customer and distributor sites.