Supervisor, Quality

Integer Holdings Corporation•Hudson, MA

1d•$88,275 - $129,470

About The Position

The Supervisor, Quality is a functional leader within the quality organization, coordinating team deliverables and providing daily direction to quality professionals, including quality engineers and technicians. The role helps ensure that quality requirements, performance goals, and improvement objectives are achieved at a manufacturing site, with a primary focus on managing performance and supporting the growth and development of direct reports. The supervisor supports manufacturing operations, reviews and approves engineering change requests, nonconformance reports, and engineering reports, and ensures compliance with the established Quality Management System. The role leads or supports process improvements, corrective and preventive actions, complaint investigations, nonconforming material investigations and dispositions, and quality audit activities. It also applies data analysis and root-cause practices to address product and process failures and identify improvements. The position contributes to Integer’s strategic manufacturing imperatives, including standardization, sustained change, associate engagement, and systems and process optimization. Performance is measured across safety, quality, delivery, cost, and people objectives. Integer describes itself as a medical device contract development and manufacturing organization serving cardio and vascular, neuromodulation, and cardiac rhythm management markets.

Requirements

Bachelor’s degree or higher in an engineering or related technical field.
At least 3 years of experience.
Knowledge and experience with the product line or function supported, such as manufacturing quality, supplier quality, or quality engineering.
Specialized knowledge of quality system regulations and standards relevant to the role, such as EU MDR, ISO 13485, ISO 9001, Good Manufacturing Practices 21 CFR 820, and Good Documentation Practices.
Auditing experience.
Ability to lead, create and communicate a coordinated vision, and align a team to address and resolve work.
Ability and preference to work in a team environment and establish a team-first expectation.
Ability to remain calm in a fast-paced, complex, and changing manufacturing environment.
Ability to work independently and collaboratively with associates and cross-functional teams.
Solid technical aptitude and ability to contribute to a team or produce technical results independently.
Effective written, oral, and interpersonal communication skills.
Problem-solving, decision-making, and bias-for-action skills.
Positive, can-do attitude.

Responsibilities

Coordinate team deliverables and provide daily direction to quality professionals to achieve site quality requirements, performance goals, and improvement objectives.
Manage the performance, growth, and development of direct reports, including supporting their Individual Development Plans.
Supervise, coach, and direct a team of quality professionals supporting one or more product lines or process areas.
Establish daily, weekly, and monthly objectives for team members and ensure effective communication throughout the team.
Provide first-level support for day-to-day issues and seek cross-functional or organizational support when needed.
Review and approve engineering change requests, nonconformance reports, and engineering reports.
Drive risk-based process control and ensure compliance with the established Quality Management System.
Support corrective and preventive action investigations and implementation, and contribute to quality KPI attainment.
Apply data analysis and observe products and processes to establish root causes of failures and support or drive improvements.
Support internal and external quality audit activities, as applicable.
Ensure investigation and disposition of nonconforming materials follow applicable procedures and that corrective actions prevent recurrence.
Lead and manage complaint investigations.
Participate in plant CAPA activities, including analysis of complaint, supplier quality, nonconforming material, training effectiveness, and root-cause data and trends.
Support strategic initiatives through site quality planning, metric updates, customer change notifications, continuous improvement, 5S, standard work, training and certification, standardized problem solving, safety programs, and production-system optimization.
Actively support Integer Environmental, Health & Safety programs and promote associate engagement.
Handle associate relations issues in a timely manner and support assigned projects and milestones.
Perform other duties as needed and directed by the manager.

Benefits

Base salary and a cash-based incentive program.
Medical insurance.
Dental insurance.
Vision insurance.
Disability insurance.
Life insurance.
Adoption benefits.
Parental leave available after one year.
Optional employee-paid supplemental life insurance, critical illness, hospital indemnity, and accident insurance.
401(k) plan with company matching contributions.
80 hours (10 days) of company-designated holidays per year.
Annual allotment of paid time off.