Asst Mgr QA

About the Role

Responsible for managing the quality and compliance for applicable products and processes within assigned areas. This position assumes responsibility for a subset of individual projects supporting the division and/or manufacturing area, compliance, and new product development as needed by the team.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the product life cycle and regions of distribution.
• Build and maintain appropriate product documentation (e.g., Device Master Records, Design Controls, Risk Management, and CE Technical Files) in compliance with applicable regulations.
• Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, and other required documentation.
• Act as a liaison with Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products and customer satisfaction.
• Assist in complaint trend investigations and develop new approaches to solve identified problems.
• Identify, implement, and manage the execution of continuous improvement projects.
• Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.
• Plan design, inspection, process validations, and coordinate testing to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction in a timely manner.
• Resolve issues relating to product or production quality by interfacing with internal and external customers.
• Lead investigations of product and process non-conformances and out-of-specification results, collaborating with supplier representatives to develop effective corrective and preventive actions (CAPA, SCAR).

Management Responsibilities

• Typically manages teams of 2-3 employees, depending on workload and required involvement with direct reports (e.g., QCs, QA/Sr QA Technicians, AQS, AQE, QS, and QE).
• Oversees day-to-day operations of a group of employees.
• May have limited budgetary responsibility and usually contributes to budgetary impact.
• Interprets and executes policies for departments/projects and develops them.
• Recommends and implements new policies or modifications to existing policies.
• Provides general guidelines and parameters for staff functioning.
• Plays a key role in hiring staff, recommending pay increases, conducting performance reviews, training and developing staff, estimating personnel needs, assigning work, meeting completion dates, and interpreting and ensuring consistent application of organizational policies.

Requirements

• A Bachelor’s degree in Engineering, Science, Math, or a related field is required, or equivalent experience.
• At least 3 years of Quality Engineering experience.

Skills

• Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO 13485).
• Experience analyzing and reporting data to identify issues, trends, or exceptions to drive improvement and find solutions.
• Experience controlling and coordinating concurrent projects, competing priorities, and critical deadlines.
• Experience leading teams to accomplish cross-functional goals.
• Strong time management skills to prioritize, organize, and track details to meet deadlines of multiple projects.
• Proficiency in MS Office Suite products (Word, Excel, PowerPoint, Outlook), including intermediate skill level in Microsoft Excel (e.g., conditional formatting, tables, formulas, charting).

Position requires travel up to 25% of the time for business purposes (within state, out of state, and/or internationally).

Pay

The anticipated salary range for this position is $101,000.00 - $152,000.00 annually. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Additional benefits for employees working 30 or more hours per week on average, including access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.