Manager, Quality Assurance & Regulatory Affairs

Description

The role covers setting up, maintaining and steadily improving the site quality management system, along with regulatory affairs for assigned locations. You will work with site management and staff to plan, build, roll out and refine QMS requirements that apply to the site, keeping it compliant with customer, state, federal and international rules in tightly regulated fields such as medical devices and FDA-governed products.

The company is a global provider of marketing, packaging, print and supply chain solutions. It works with 22,000 clients, including 93% of the Fortune 100, and has 32,000 employees across 28 countries. Its services aim to reduce environmental impact.

Responsibilities

• Lead and support the upkeep and ongoing improvement of the site QMS across food, medical device and pharma manufacturing.
• Manage a team of quality engineers, supervisors, specialists and auditors.
• Oversee software quality activities.
• Lead product release for medical devices.
• Advise sites on process validation strategies.
• Coordinate work to keep quality system requirements current, including ISO 13485:2016, ISO 9001:2015, ISO 14971, ISO 11137, EUMDR and FDA QSR.
• Escalate significant or possible quality problems to site management, and lead root cause analysis and corrective and preventive actions to reduce or remove errors.
• Track and measure QMS processes, including quality objectives, CAPAs, NCMRs and preventive actions.
• Draft and approve quality agreements with customers and suppliers.
• Apply a risk-based approach to the site QMS and operations.
• Build quality plans for major changes and rollouts.
• Lead the setup of new products.
• Set up and monitor cleanroom and environmental controls, working with the sterilization vendor.
• Drive effective use and further rollout of eQMS systems.
• Handle quality input for customer RFPs and RFIs for the site, including customer contact.
• Lead the internal audit program.
• Direct quality department staff.
• Make sure every deviation investigation is completed properly and recorded.
• Manage quality and regulatory staff at more than one site where required.
• Take on other duties as assigned.

Requirements

• Bachelor's degree in a technical field or one of the life sciences.
• 5+ years of related work experience, including team leadership.
• 3 years of QA or RA experience in medical devices or pharma.
• Advanced training or experience in ISO 13485:2016, ISO 14971:2019 and FDA QSR.
• Ability to read and interpret federal regulations and company operating procedures for regulated manufacturing.
• Experience with ISO class cleanrooms and qualifying sterile production is desirable.
• Ability to set priorities and handle several tasks with little supervision.
• Knowledge of USDA organic food manufacturing requirements.
• ISO Lead Auditor or ASQ Certified Auditor credential.
• Working knowledge of PC systems and Microsoft Word and Excel.
• Strong written and verbal communication skills.
• Certification in ISO 13485 is desirable.

Conditions

The current salary range for this role is $107,000 to $171,200 per year. The range may vary by the hired employee's location and may change over time.

Hires are rarely made at or near the top of the range. Pay decisions may depend on factors such as education, skills, experience, proficiency, performance, shift and location.

Depending on the role, total compensation may also include a bonus, commission or incentive plan.

All offers depend on passing a pre-employment background check and drug screen.

Candidates should not use AI tools during interviews.

Equal opportunity employer, including disability and veterans.

Benefits

• Medical, dental and vision coverage.
• Paid time off.
• Disability insurance.
• 401(k) with company match.
• Life insurance and voluntary supplemental insurance.
• Parental leave and adoption assistance.
• Tuition assistance.
• Employer and partner discounts.