Senior Quality Assurance Engineer

Job Description:

Responsible for the process related Quality Management and Quality Assurance at the production site of Nobel Biocare AB, located in Karlskoga.

The position shall ensure that processes and procedures, including ISO13485 and FDA QMSR , needed for securing quality and compliance for the manufacturing of the site products are supported.

The position also engages in continuous improvement and supports the awareness of GMP at the site.
Additionally the position in it’s responsibilities and accountabilities cooperates crossfunctionally with the site departments, sister sites, our distribution center as well as the Head Office.
 

Job Requirements:

The Quality Assurance Engineer participates in the development and implementation of the QMS according to current FDA regulation, ISO13485 standard and other applicable Quality system regulations.
This position in Quality Assurance is responsible for supporting or taking active part in audits, to secure investigations of non-conformances, secure implementation of corrective and preventive actions as well as be part  of developing the processes with in Quality.

Critical Knowledge and Qualifications:

• Experience from production and process industry
• B.SC, M.Sc or equivalent work experience in relevant area
• Knowledge on Continuous Improvement
• Experience in driving Quality culture

Critical Skills/technical know-how:

• Fluency in Swedish and English, both spoken and written
• Well developed communication skills
• Analytical ability to evaluate information and decision making
   

Critical Experience:

• More than 5 years experience in regulated process industry or equivalent experience
• experience in Quality Assurance work in industries such as medical device, pharmaceutical or food industry
• Good ability to cooperate in a matrix organization
   

Additional experience in Statistical process analysis and/or SPC is an advantage

#LI-PG2

Operating Company:

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.