Envista

Global dental products & technologies provider

Head of Quality Assurance

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours

Full-timeSwedenNo salary listed

About the Job

Requirements

Proven expertise in designing and implementing quality processes in a regulated manufacturing organization.
Experience developing an organizational culture that promotes and sustains quality.
Strong proficiency in process, software, and sterilization validation methodologies.
Practical experience with risk management tools such as PFMEA.
Strong leadership and ability to influence cross-functional teams, including Manufacturing and R&D.
Objective problem-solving skills and ability to make firm, risk-based quality decisions under pressure.
High attention to detail and scientific rigor.
Fluency in spoken and written English is mandatory.
More than 5 years of experience in a regulated process industry.
Professional experience in quality management in industries such as medical device, pharmaceutical, or food.
Experience in management positions.

Responsibilities

Lead and develop the Quality department, consisting of QC and QA.
Ensure awareness of applicable regulatory and quality management system requirements throughout the organization.
Ensure process risk assessment files comply with ISO 14971.
Ensure validations are robust, monitoring activities are performed and analyzed, and revalidation cycles are overseen.
Ensure manufacturing process changes are properly assessed.
Partner with manufacturing engineering to optimize inspection and testing methods.
Supervise incoming inspection and final product release, including Device History Records.
Ensure timely resolution of Corrective and Preventive Actions.
Oversee site document control and training processes.
Act as the primary site contact for internal and external audits.
Lead, maintain, and continuously improve the site Quality Management System to support compliance, product safety, and efficacy.
Ensure production processes remain controlled and that validations and processes meet specifications, applicable regulatory requirements, and patient safety standards.

Desired Qualifications

Swedish language skills are welcome.
Sound understanding of SAP systems.

Job Description:

The Head of Quality Assurance is responsible for Quality Assurance and Quality Control at the production site of Nobel Biocare AB, located in Karlskoga, Sweden. This position ensures the manufacturing site complies with applicable international medical device regulations and standards. A key responsibility will be to lead, maintain, and continuously improve the site Quality Management System (QMS) to guarantee product safety and efficacy. This role focuses on ensuring that production processes remain in a state of control, validations are robust, and processes consistently produce medical devices that meet specifications, Regulatory requirements (ISO 13485 / FDA 21 CFR 820), and patient safety standards.

Lead and develop the Quality department consisting of QC and QA

Ensure the awareness of applicableRegulatory& QMSrequirements throughout the organization

Ensure process risk assessment files are in accordancetoISO 14971

Ensure validationsare robust, monitoring activities are performed and analyzedand oversee revalidation cycles

Ensure manufacturing process changes are properly assessed

Partner withmanufacturingengineering to optimize inspection and testing methods

Superviseincoming inspection as well asfinal product releaseincludingDevice History Records (DHR)

Ensure timely resolution ofCorrective and Preventive Actions(CAPA)

Oversee the document control and training processesat the site

Act as the primary site contact forinternal and externalaudits

Job Requirements:

Proven expertise in design and implementation of Quality processes into a manufacturing organization in a regulated industry
Experience with the development of anorganizational culture that promotes and sustains Quality
Strong proficiency in validation methodologies (process, software, sterilization)
Practical experience with risk management tools (f.e.PFMEA)
Strong leadership and ability to influence cross-functional teams(f.e Manufacturing, R&D)
Objective problem-solving skills with the ability to make firm, risk-based quality decisions under pressure
High level of attention to detail and scientific rigor
Fluency(oral and written)in English is mandatory,Swedish iswelcome
SoundSAP system understanding is a plus
More than 5 years experience in regulated process industry
Professional experience in Quality Management in industries such as medical device, pharmaceutical or food industry
Experience in Management positions

#LI-PG1

Operating Company:

Nobel Biocare

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.

About the Company

Envista

Global dental products & technologies provider

Envista provides a broad range of dental products and solutions to dental professionals, spanning implants, prosthetics, orthodontics, imaging, endodontics, restorative materials, and infection prevention. Its products work by serving dentists through a two-segment model: Specialty Products & Technologies (brands like Nobel Biocare, Ormco, Damon System, Spark) and Equipment & Consumables (brands like Kerr, DEXIS, Metrex) sold via direct sales and distributors to offices, clinics, hospitals, and labs, enabling end-to-end workflows from planning and imaging to treatment and infection control. Envista differentiates itself with a large, globally distributed portfolio and established brands that cover roughly 90% of a dentist’s clinical needs, supporting DSOs and independent practices alike. The company aims to be a leading independent global provider of dental products and digital dentistry tools, expanding geographic reach and integrated solutions for dental care.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Brea, CA
Founded: 2004

Recently Posted Jobs

Explore more opportunities at Envista

See more jobs