Daniel Christiansen Email & Phone Number

Saint Paul, Mn, Us

Eden Prairie, Minnesota, Us

Quality Systems Management

Minneapolis, Mn, Us

Supporting Audits and Acquisitions

Owning and supporting high profile CAPAs.

Marlborough, Ma, Us

Supporting Customer Complaint Analysis activities.Updating EU MDR documentation.

St Petersburg, Florida, Us

NPI products

Galway, Ie

Marlborough, Ma, Us

C0-conduct 16 internal audits seeking improvement options. Help teach new lead and guest auditors.Key Achievements:• Began lead auditor qualification studies.• Reviewed corporate glossary with 2,300 terms and transferred 40 to global version.• Earned contract extension. • Completed continuous improvement project suggestion and trial run.

Amsterdam, Noord-Holland, Nl

Trained CAPA owners on CAPA initiative. Led cooperation between Remediation Team, CAPA owners, and CAPA Review Board.Key Achievements:* Received two contract extensions.* Mentored less experienced CAPA Coordinators

Brooklyn Park, Mn, Us

Assessed and updated CAPA procedures and forms. Established new CAPA Board. Directed or aided internal audits.Key Achievements:* Completed 39 CAPAs in 3 months.* Created and delivered ISO 13485:2016 training course for engineers* Rewrote CAPA process procedures and formsLead Auditor * Lead or assisted in 10 Audits

Fairfield, New Jersey, Us

Analyzed and refreshed internal and vendor quality programs. Completed nine internal audits.Key Achievement:* Revived Internal auditing process neglected for 18 months due to personnel departures.* Created and began executing audit schedule to ensure regulatory compliance.* Performed nine internal audits in three months.

Facilitated Root Cause Analysis methodology training for CAPA resolution. Authored quality strategies based on root cause analysis results. Reviewed and solved customer complaints. Taught and mentored Lean Six Sigma tools to build teams and develop individuals. Served on team devising product distribution roadmap and elements. Prepared management review slide presentations. Maintained and enhanced quality systems programs and protocols. Managed Calibration Program and oversaw Vendor selection.* Aided merger of three quality systems into one.* Worked on backroom team during two FDA inspections and restored quality system from failing FDA audit to passing within one year.* Appointed primary expert during notified body and internal audits and quality engineer for all products during transition.* Revised FEMAs with customer complaint information.

St. Paul, Minnesota, Us

Devised matrix connecting all SOPs and some WIs to required regulations and standards. Aided ISO13485 efforts supporting validations. Facilitated management review slide decks. Assisted with SPC Data Analysis. Managed on-site internal audit and training programs. Trained and supervised 4 veteran auditors. Conducted ISO13485 and 14001, FDA 820, MDR, MDD, and MHLW audits. Served as complaint investigation expediter/liaison between Post Market Surveillance, Tech Services, and Returned Product Investigation to expedite closure of complaints..* Assisted with merger of six quality systems into one.* Oversaw transformation from manual system to new automated system.* Spearheaded on-site CAPA program for site guaranteeing accuracy of documentation and designing forms and procedures to improve participation and expediency.* Raised on time training completions from 97.49% in December 2012 to 99.93% in September 2013).* Increased on time CAPA performance from 55% late CAPA reporting in March 2010 to zero in 3 months (Q3 2012).* Improved on time internal audit completion rate from 71% in 2011 to 100% in 2012.* Performed ISO14000 audit.

Authored more than 180 IOQ protocols on equipment including Laser cutting and welding and enclosures, injection molding, coil winding, and EDM cutting machines, Swiss machining, and more. Helped execute IOQs and PQs. Confirmed documentation completion.* Wrote protocols to combine five sites into three.

Bachelor Of Applied Science, Business Management

Associate'S Degree, Liberal Arts And Sciences/Liberal Studies