Quality Assurance Engineer (On-site - Acton, MA.)

The Quality Assurance Engineer will be a critical contributor in a mission that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.
The successful candidate will be responsible for providing Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. It requires creativity and foresight to work with other functions to ensure compliance and the accomplishment of departmental and company goals. The position requires working alongside with engineering, purchasing, suppliers, and manufacturing to support the manufacturing operations and continuous improvement initiatives.
Responsibilities:
 

• Lead/assist in CAPA activities (perform and document Root Cause Investigations, formulate corrective and preventive actions, and implement those actions).

• Write and review quality documentation such as procedures, test protocols and reports.

• Write and review protocols/reports of Process and Test Method Validations.

• Develop and/or manage quality programs related to the resolution of issues arising from manufacturing operations as well as post manufacturing activities. Provide QA Engineering support and expertise to Manufacturing, Engineering, and other company functions.
• Work with operations/manufacturing and the contract manufacturer to lead efforts to resolve issues that involve quality system gaps, production non-conformances or situations that involve component qualification or procurement.

• Support Risk Management activities and ensure compliance to standards and regulations.

• Support activities as it pertains to sterilization release, sterilization validation, biocompatibility, design verification, design validation and other associated validation and qualification activities.

• Lead/assist in the creation of statistical techniques for metric generation methods.
• Lead/assist in the development of risk-based assessments to determine inspection requirements and acceptance criteria.

• Support site during external audits (i.e., FDA, BSI, customer).
• Performs other duties as assigned.
Minimum Requirements:

• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or 3 + years experience in a full-time technical or engineering role will be considered in lieu of a degree.
• A minimum of 2 years work experience in Quality Assurance within an FDA, ISO or other regulated environment.
Preferred Skills and Competencies:

• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820), ISO 13485 Medical devices – Quality management systems, and ISO 14971 Medical devices – Application of risk management to medical devices.
• Fluent in computer skills, and at minimum, the use of Microsoft Office programs (e.g. Word, Excel, Access, PowerPoint).
• Demonstrated experience organizing and maintaining large documentation sets.
• Ability to follow up with task owners to close out open items.
• Familiarity with FDA, ISO, and other international regulatory requirements.
• Effective verbal and written communication skills.
• Experience collaborating and communicate with individuals at multiple levels in an organization.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Skilled in computer use including word processing, spreadsheet, and database applications.

• Knowledge of applied statistics (sampling plans, Cpk, population comparison, confidence analysis etc.) required.
• Proficient in Statistical Software for data analysis (Minitab preferred)

• CQE and/or CQA certification is desirable  
Physical Requirements:

• Able to travel internationally and domestically (5%)

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite 

Additional Information:

The US base salary range for this full-time position is $68,700.00 - $103,050.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.