Quality Assurance Engineer 1 - Chemical Compliance

Marlborough, MA, United States

Louisville, CO, United States

Why Hologic?

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

Our innovations are designed to achieve exceptional clinical results, making it possible to detect, diagnose and treat illnesses and other health conditions earlier and more effective.

Our goal is to minimize doubt and maximize the confidence our customers and their patients have in their decisions and diagnoses.

What to expect:

The Chemical Compliance Quality Specialist is responsible for developing, implementing, and maintaining Quality Management System (QMS) procedures and work instructions related to chemical compliance within the division. This role serves as a liaison between the Corporate Chemical Compliance group and the division, ensuring regulatory and QMS changes are assessed and implemented. The specialist leads the quarterly Chemical Compliance review process, monitors Key Process Indicators (KPIs), and supports product development and engineering teams as a Subject Matter Expert. Additionally, this position involves assessing product compliance, reviewing engineering changes, conducting production record reviews, and performing investigations.

What we expect:

• Develops, implements and maintains Quality Management Systems procedures and work instructions for Chemical Compliance Management in the Division.

• Serve as a liaison between the Corporate Chemical Compliance group and the Division. Responsible for performing assessments to new or emerging regulatory or Quality Management System changes. Supports implementation of applicable changes to impacted processes

• Leads the quarterly Chemical Compliance review process. Works with cross divisional team members for the appropriate closure of action items.

• Develop, monitor and communicate Key Process Indicators (KPIs) related to Chemical Compliance of products within the division. Communicate to management representative any escalations or adverse trends identified to determine the needs for corrective action. Lead with oversight from manager corrective actions, as needed.

• Provide support to Product Development and sustaining engineering teams, as Subject Matter Expert in Chemical Compliance regulations and applicable Quality Management System processes.

• Assesses product compliance to Chemical Compliance regulations and develops action plans if required. Monitors Chemical Compliance status accuracy in the centralized system platform.

• Responsible for review of Engineering Change Orders impacting product components to ensure impact to Chemical compliance is assessed and Quality Management system requirements are met.

• Review of production record and lot release documentation to guarantee documented requirements and specifications are met. Ensure storage of Device History Record and Lot Release documentation according to specified procedures.

• Performs moderate to complex investigations with detailed clarity into root cause.

• Assists in cross functional projects with supervision.

Education & Experience:

• Bachelor’s degree in Chemical Engineering or Scientific field preferred.

• Education and experience sufficient to successfully perform the essential functions of the job may be considered.

• 1+ years in Quality roles in a medical device manufacturing environment preferred

• 1+ years in Quality roles in a production environment preferred

The annualized base salary range for this role is $62,900 to $98,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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