Senior Quality Assurance Engineer
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Role Overview
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.
Key Skills for This Role
Full Job Posting
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
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Target Market Salary Range
- Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
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.
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
About Nobel Biocare
Parent group profile
Envista Holdings Corporation
Global dental products company comprising over 30 trusted brands.
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