- Lead Arden Hills External Audit preparation, execution, and closure activities, including leading the nonconformance responses process if necessary
- Backroom Manager for Quality System external audits executed in Arden Hills
- Primary Arden Hills representative on the External Audit Global Community of Practice
- Lead the response to Quality System information requests from other BSC sites
- Lead information gathering and preparation activities for applicable global QS meetings and forums (e.g., audit readiness, signals review)
- Lead and/or support Quality System-related education initiatives
- Lead and/or support Quality System Sub-Process integration activities related to external audit readiness
- May educate functional areas on quality system requirements
- Work with Quality and other leaders to identify areas within the quality system in need of improvement and manage Corrective and Preventive Actions as appropriate
- Promote a work environment that supports the global Quality Policy, global Quality System, Continuous Improvement and Winning Culture at Arden Hills
- Act as an effective leader or team member in supporting quality disciplines, decisions, and practices
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities
- Bachelor's degree and 5+ years relevant experience or Master's degree with 3+ years relevant experience, preferably in medical device industry
- Comprehensive working knowledge, interpretation and application of all regulations and standards listed in the BSC Global Policy Quality System Management, including but not limited to: 21 CFR Part 820, ISO 13485, EU MDR 2017/745, AIMDD, MDD, MHLW Ordinance 169, MDR SOR/98-282, 21 CFR Part 211, ISO 14971, Therapeutic Goods Regulations 2002, Resolution RDC 16/2013, 21 CFR Part 4, as applicable to site
- Comprehensive working knowledge, interpretation and application of Medical Device Single Audit Program (MDSAP) program
- Experience managing, coordinating, or supporting external audits of medical device quality systems
- Excellent verbal / written communication, interpersonal, project management, and organizational skills
- Ability to understand procedural documents and evaluate documents to ensure compliance to all applicable regulations and requirements
- Ability to demonstrate equanimity, effectiveness, and leadership in challenging situations
- Ability to communicate with all levels of the organization
- Must be proactive, work independently, and be a contributing member of a highly visible team
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Senior Quality Systems Engineer - Arden Hills, United States - Boston Scientific
Description
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
About This Role: The Senior Quality Systems Engineer position reports directly to the Senior Manager, Quality Systems, Arden Hills, Minnesota.
The suitability, adequacy, and effectiveness of Boston Scientific's Quality System as implemented throughout the Arden Hills, Minnesota site is audited frequently by various external regulatory compliance authorities (e.g., FDA, BSI, DEKRA, TUV-R, and other geography-specific agencies from around the world). The Sr Quality Systems engineer position leads and coordinates all efforts regarding external audit preparation, execution, and closure activities for each audit. The primary responsibilities of the role include interfacing directly with Arden Hills Quality System Process and Sub-Process owners, Subject Matter Experts, and Management and Global Quality Systems personnel, as needed, to ensure functions are clear regarding scope of each audit and expectations of readiness to support all audits involving those functions. Responsibilities include logistical preparation such as developing audit support staffing plans, communicating status of audit preparation, and leading preparation meetings with SMEs. This position also responds to Quality System information requests from worldwide Boston Scientific locations and may support additional activities such as Quality System integration and/or provide general support for other initiatives and projects.
Your Responsibilities Will Include:
Required Qualifications
Preferred Qualifications
Requisition ID: 580881
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § , Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.
