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Beaver-Visitec International Principal Quality Systems Engineer in Waltham, Massachusetts

A Heritage of Precision, Innovation and Quality

Beaver-Visitec International is focused on developing and manufacturing new, innovative and reliable products for a variety of ophthalmic and specialty microsurgical procedures. Our products are distributed worldwide by sales and marketing professionals recognized throughout the industry for their clinical expertise and outstanding customer service.

Beaver-Visitec International currently seeks talented professionals to help create and promote innovative, new microsurgical products for ophthalmic surgery.

Reporting directly to the Sr. Director of Quality, the Principal Quality Systems Engineer is an experienced professional with wide-ranging experience and expertise who supports the continuous improvement, oversight and integrity of the BVI Quality Management System.

The Principal Quality Systems Engineer supports the development and maintenance of quality system programs, policies, processes, procedures and controls ensuring that performance and quality of the Quality Management System complies with regulation, standards and agency guidelines. Reviews, analyzes and reports on quality performance and processes and develops corrective actions for recurring discrepancies. Submits appropriate metrics and reports to the site quality management and/or to corporate as part of the Management Review process.

  • Interface with assigned cross functional global departments, manufacturing, engineering, customer, vendor and subcontractor representatives to facilitate compliance, assists in determining responsibilities and solutions when required.

  • Lead Internal Audits and support External Audits.

  • Reviews and monitors compliance with cGMP practices.

  • Maintains compliance to the BVI Quality Management System; manage and maintain effectiveness of Quality Management System; supports submittal of reports summarizing various trend analyses on their defined and applicable quality system clauses and corresponding quality objectives; facilitates the awareness of quality, regulatory and customer requirements throughout the organization.

  • Lead and/or coordinate QMS Review Boards

  • CAPA Process Owner and Facilitator; Complete Quality Systems Related CAPAs of local and global scope; Lead CAPA Review Board

  • Assists in the development and continuous improvement of SOPs and Work Instructions.

  • Support implementation of Process and/or Compliance Improvement initiatives.

  • Encourages robust problem-solving methodologies

  • Enable sharing of best practices, initiatives/ideas and accomplishments across the business.

  • Strong understanding of Quality Management Systems as defined in 21CFR820 and ISO 13485, MDD/MDR, CMDR.

  • 8+ years of medical device experience preferred

  • Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 806, 807 and 11 is required, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, and other standards applicable to the international medical device industry.

  • Experience with implementation and maintenance of multiple Quality System Elements.

  • Experience in nonconforming material and CAPA methodologies/systems

  • Detailed understanding and working knowledge of US and International regulations including 21CFR820, 803, 806, 807 and 11 is required, as well as the Medical Device Directive/ Medical Device Regulation, EN ISO 13485, EN ISO 14971, and other standards applicable to the international medical device industry.

  • Strong technical writing, communication and presentation skills.

  • Competent with use of Microsoft Office Suite and Minitab Statistical Analysis software (or equivalent).

  • Applies continuous improvement principles in development of the quality system.

  • Experience with all aspects of third-party audit activities (e.g. Front Room / Back Room, Closure of Non-Conformances, etc.)

  • Driven, energetic, self-assured professional with high personal integrity.

  • Ability to develop effective, positive interpersonal relationships.

  • Certified DMAIC or DFSS Green or Black Belt strongly preferred

  • Experience in working in a global, matrixed organization.

  • Experience with the planning, implementation and maintenance of an Electronic QMS Solution preferred.

  • ASQ Certification (e.g. CQA, CQE) strongly preferred;

Beaver Visitec International is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.

External Company URL: www.beaver-visitec.com

Street: 500 Totten Pond Rd-

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