Senior Quality Engineer

Spectra Medical Devices, LLC.; Wilmington (MA); On-site; USD 115,000 - 130,000; Full time

Job summary

Elevaris Medical Devices is seeking a Senior Quality Engineer to lead supplier quality programs and drive CAPA investigations in a medical device environment. The role includes audits, nonconforming material handling, and interaction with customers and suppliers to ensure compliant, high-quality outputs.

Responsibilities cover SCAR and CAPA processes, supplier qualification, regulatory compliance with ISO 13485, FDA QSR and EU MDR, plus risk management and continuous improvement initiatives

Qualifications

• Bachelor’s degree preferably in Engineering, Science or Math or equivalent/relevant experience including 5+ years’ Quality Engineering in a manufacturing or industrial environment, preferably in an FDA/ISO regulated environment.
• Knowledge of statistical sampling and analysis
• Strong Knowledge of ISO 13485, FDA QSR, ISO 14971 and EU MDR concepts and guidelines as well as other national and international regulations and standards
• Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
• Technical writing experience
• Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Six Sigma, Lean manufacturing, etc.).

Responsibilities

• Investigation, evaluation and reporting of adverse event incidents or device malfunctions as required by FDA and international regulatory authorities
• Provide support of nonconforming material (NCR) and customer complaints, perform investigations, material dispositions, and communicate with customers and/or suppliers
• Facilitate supplier corrective action (SCAR) subsystem, communicate with suppliers, and follow up on investigations and corrective action planning and implementation by suppliers
• Support corrective and preventive action (CAPA) subsystem, perform investigations, follow up on corrections, root cause investigations, corrective action plan, implementation, and effectiveness verification plan
• Perform the qualification of new and existing suppliers, perform supplier audits, monitor supplier performance provide scorecards, and other related supplier management activities
• Facilitate the execution of Risk Management activities
• Conduct Gage R&R and validations as needed
• Identify statistically based sampling plans for inspections and testing
• Support activities to ensure compliance with cGMP, QMSR, ISO 13485, MDD/ MDR, ISO 14971 and other applicable regulations and/or standards
• Participate in internal and external (ISO, MDD/MDR, customer, supplier) audits and FDA inspections
• Support Post-Market Surveillance (PMS) activities as required
• Collect and report Quality metrics and data as required
• Identify and implement opportunities for continuous improvement
• Perform other Quality System related duties as required communicate with customers and or suppliers as needed providing compliance information i.e., RoHS, conflict materials, prop 65 etc. as needed.
• Communication of change notices as applicable
• Support development of control plans, validation plans and inspection procedures for new product development projects

Skills

Statistical analysis

GD&T reading

Quality audits

Six Sigma/Lean

CAPA/SCAR management

Regulatory knowledge (FDA QSR, ISO 134

Education

Bachelor’s degree in Engineering, Science or Math

Tools

MS Office

Visio

Project

Minitab

Job description

At Elevaris, our goal is not to be good, it's to be extraordinary.

Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field.

Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

About the role

The desired candidate will have prior experience as a Senior Quality Engineer, preferably working in a medical device company. Specific experience and responsibilities include but are not limited to maintaining the supplier quality program (agreements, performance etc.), Supporting Customer Complaints; performing failure investigations; supporting Non-Conforming Material; managing corrective and preventive actions; supporting the internal audit program, execution of Gage R&R and validations and driving a continuous improvement program.

Please note this position is onsite in Wilmington Mass.

What you'll do

• Investigation, evaluation and reporting of adverse event incidents or device malfunctions as required by FDA and international regulatory authorities
• Provide support of nonconforming material (NCR) and customer complaints, perform investigations, material dispositions, and communicate with customers and/or suppliers.
• Facilitate supplier corrective action (SCAR) subsystem, communicate with suppliers, and follow up on investigations and corrective action planning and implementation by suppliers
• Support corrective and preventive action (CAPA) subsystem, perform investigations, follow up on corrections, root cause investigations, corrective action plan, implementation, and effectiveness verification plan
• Perform the qualification of new and existing suppliers, perform supplier audits, monitor supplier performance provide scorecards, and other related supplier management activities.
• Facilitate the execution of Risk Management activities
• Conduct Gage R&R and validations as needed
• Identify statistically based sampling plans for inspections and testing
• Support activities to ensure compliance with cGMP, QMSR, ISO 13485, MDD/ MDR, ISO 14971 and other applicable regulations and/or standards
• Participate in internal and external (ISO, MDD/MDR, customer, supplier) audits and FDA inspections
• Support Post-Market Surveillance (PMS) activities as required
• Collect and report Quality metrics and data as required
• Identify and implement opportunities for continuous improvement
• Perform other Quality System related duties as required communicate with customers and or suppliers as needed providing compliance information i.e., RoHS, conflict materials, prop 65 etc. as needed.
• Communication of change notices as applicable
• Support development of control plans, validation plans and inspection procedures for new product development projects

Qualifications

• Bachelor’s degree preferably in Engineering, Science or Math or equivalent/relevant experience including 5+ years’ Quality Engineering in a manufacturing or industrial environment, preferably in an FDA/ISO regulated environment
• Knowledge of statistical sampling and analysis
• Strong Knowledge of ISO 13485, FDA QSR, ISO 14971 and EU MDR concepts and guidelines as well as other national and international regulations and standards
• Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T)
• Technical writing experience
• Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Six Sigma, Lean manufacturing, etc.).

Preferred Skillset:

• Sterile background a plus
• Excellent organizational, verbal, written communication and problem-solving skills
• Reliability and attention to accuracy, detail, and timeliness; reporting and analyzing information skills
• Able to work in a fast-paced environment and meet strict deadlines
• Self-motivated and can work with minimal supervision
• Proficient in MS Office suite, Visio, Project and MiniTab

PHYSICAL DEMANDS & ADA STATEMENT:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by a contractor to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the contractor is regularly required to be independently mobile. The contractor is also required to interact with a computer and communicate with peers, co-workers and external partners. Contact your manager or HR to understand the Work Conditions and Physical requirements that may be specific to your role.

An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company will not discriminate or tolerate discrimination against any contractor or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-contractor relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination. Disabled applicants may request any reasonable accommodation needed to enable them to complete the application process.

The pay range for this role is:

115,000 - 130,000 USD per year (Wilmington MA)