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.

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.

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