Fang Consulting specializes in Medical Device Regulatory Affairs and Quality Assurance in the midst of Minnesota’s Medical Alley. Our work is serious, but our office is fun!
We are looking for an experienced quality professional with quality engineering as well as quality systems experience to add to our growing team. If you are interested in working in a fast paced, dynamic atmosphere and can assess a situation, fill gaps and put a strategic plan in place to move forward to meet client’s compliance and business needs, we’d love to hear from you!
What you will do:
• Select and interpret US and International quality system requirements.
• Ensure quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations.
• Manage and support the effectiveness of quality systems for virtual companies through monitoring and measurement activities.
• Write ISO 13485 and ISO 9001 quality manuals, procedures, and work instructions.
• Conduct gap analyses, pre-audits, and internal audits.
• Provide supplier quality support by performing audits and insuring follow up activities are completed.
• Perform CAPA remediation and gap analysis.
• Perform risk management activities and reviews to support product and process risk files.
• Provide quality engineering support to meet client design and manufacturing needs done through protocol and report reviews, data analysis and trending activities.
What we’re looking for:
• Someone who can see the big picture and rapidly, efficiently sort out priorities.
• 3 years of quality systems and/or engineering and auditing experience.
• Audit experience including ISO 13485, MDSAP, and FDA QSR.
• Proven proficiency in developing continuously improving US and international quality management systems.
• Strong technical writing skills.
• Self-directed with strong communication and follow-through.
• Ability to prioritize multiple tasks and move between them quickly.
• As cliché as it sounds, MUST LOVE DOGS.
What we offer:
• Competitive compensation, including 401(k) match, paid vacation and holidays.
• Medical, dental and life insurance.
• Flexible working hours.
• Continued education—tuition reimbursement for career development courses.
• Open office space with lots of natural light centrally located in NE Minneapolis.
• Lunch provided every day.
Fang Consulting is an equal opportunity employer; we welcome diversity and encourage veterans to apply.