Senior Quality Operations Engineer

Description

Job Title

The Senior Quality Operations Engineer is responsible for supporting a state of high-quality performance, compliance, and oversight/performance monitoring of the company manufacturing processes, driving compliance and continuous improvement throughout the manufacturing process.

Responsibilities

• Support operations performance monitoring, reporting, improvement and development, facilitate quality improvement programs in factories.
• Handles nonconformance events/investigations in the factory, leverages Process Failure Mode and Effects Analysis (PFMEA) to assess risk, guides material review board activities for non-conformance disposition management, leads analysis of defects for determining dispositions of non-conformances, drives management of Non-Conformances (NC) and facilitates implementation of effective Corrective and Preventive Actions (CAPA) actions
• Facilitates timely quality engineering and quality assurance tasks, ensures manufacturing quality systems are maintained, handles single or complex process validation and process improvement activities, and helps in completion of New Product Introduction (NPI) and product transfers in factory.
• Possesses working knowledge Quality Engineering and Continuous Improvement techniques, follows processes and operational policies in selecting methods for obtaining solutions, and frequently interacts with supervisors and functional peer groups to gain cooperation of others
• Leads validation protocols, facilitates production builds to support validation activities, analyzes data for reports, process improvement initiatives, and validation activities.
• Utilizes advanced statistical analysis methods to interpret complex data trends, resolve a wide range of moderate complexity requests, and provide strategic insights for continuous enhancement of quality standards and process efficiency.
• Ability to interpret and/or create detailed, quality metrics and reports with stakeholders, highlighting significant achievements, emerging trends, and actionable insights to drive advanced improvement initiatives and ensure regulatory compliance.
• Delivers training programs on quality standards, advanced methodologies, and best practices, fostering alignment across functions and advancing excellence in operational practices at an high proficiency level.
• Experience managing incoming inspection programs, equipment control processes (including calibration and maintenance), environmental monitoring programs (viable and non-viable) including data analysis and trending, and support sterilization, endotoxin process analysis to ensure compliance with regulatory and quality requirements.
• You're the right fit if:
• You have a minimum of 5+ years’ experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments, with a focus on quality operations, audit support, process validation/improvement, CAPA, non-conformance, PFMEA’s and Change/Risk Management (ISO 14971).
• You have proven experience leading cross-functional teams
• You have detailed experience/knowledge in CAPA processes non-conformances, including problem identification, root cause analysis, implementation of solutions to prevent recurrence and drive continuous improvement.
• You’re experienced in utilizing Quality) insights/data analytics to lead continuous improvement.
• You’re able to build/cultivate relationships with supervisors, functional peer groups, internal/external stakeholders, suppliers etc.
• Previous experience in environmental control programs and sterilization validation.
• You have a minimum of a Bachelor’s Degree in Engineering. ASQ-CQE, ISO Lead Auditor certifications-desired
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .

Conditions

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time (5 days per week) presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an ON-SITE role.

About the company:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality. healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Learn more about our business .

Discover our rich and exciting history.

Learn more about our purpose.

Learn more about our culture.

The company Transparency Details:

The pay range for this position in Bedford, MA is $102,480 to $163,968.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

At the company, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive the company Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here .

Additional Information:

US work authorization is a precondition of employment. T he company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits WILL NOT be provided for this position. For this position, you must reside in or within commuting distance to Bedford, MA.

May require travel up to 10%.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

The company is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.